Circulatory support system and method of use for isolated segmental perfusion

ABSTRACT

A circulatory support system and method for circulatory support are described for performing cardiopulmonary bypass using differential perfusion and/or isolated segmental perfusion of the circulatory system. The circulatory support system includes one or more venous cannulae for draining blood from the venous side of the patient&#39;s circulatory system, one or more arterial cannulae for perfusing the arterial side of the patient&#39;s circulatory system, and one or more blood circulation pumps connected between the venous cannulae and the arterial cannulae. The arterial cannulae and the venous cannulae of the circulatory support system may take one of several possible configurations. The circulatory support system is configured to segment a patient&#39;s circulatory system into one or more isolated circulatory loops. The circulatory loops may be isolated from one another and/or from the remainder of the patient&#39;s circulatory system on the venous side, as well as on the arterial side, for isolated closed loop circulatory support of separate organ systems. The circulatory support system is suitable for use in minimally-invasive cardiac surgery, using thoracoscopic, port-access or minithoracotomy techniques, or for standard open-chest cardiac surgery.

FIELD OF THE INVENTION

[0001] The present invention relates generally to circulatory supportsystems and cardiopulmonary bypass systems. More particularly, itrelates to a circulatory support system and method of use for isolatingorgan systems for separate closed loop perfusion.

BACKGROUND OF THE INVENTION

[0002] Circulatory support systems are used in many different medicalsettings to supplement or to replace the pumping function of a patient'sheart. Applications of circulatory support systems and methods include,inter alia, augmenting cardiac output in patients with a failing heart,resuscitating victims of severe trauma or injury, and supporting apatient's circulatory functions during surgery.

[0003] One particular type of circulatory support system, known as acardiopulmonary bypass (CPB) system, is used to temporarily replace thefunctions of the heart and the lungs by supplying a flow of oxygenatedblood to the patient's circulatory system. The CPB system drainsdeoxygenated blood from the patient's venous system, passes it through ablood oxygenator, and pumps the oxygenated blood back into the patient'sarterial system. CPB systems may be configured for direct cannulation ofthe inferior and superior vena cava or the right atrium and the aorta,or they may be configured for peripheral cannulation through the femoralvein or jugular vein and the femoral artery. The cardiopulmonary bypasssystem allows the patient's heart to be temporarily stopped, for exampleby cardioplegic arrest, hypothermic arrest or fibrillation, forperforming a variety of cardiothoracic surgical procedures.

[0004] Previous CPB systems have generally been configured to provide asingle circulatory loop for supplying the entire body with oxygenatedblood from a single CPB pump. Thus, all organ systems of the bodyreceive oxygenated blood at the same pressure and temperature and withthe same blood composition. This single-loop configuration hassignificant limitations in many medical circumstances. It has beenfound, for instance, that the optimal perfusion temperature for organpreservation during prolonged circulatory support is different fordifferent organs of the body. Likewise, different chemical compositionsof the blood are beneficial for preservation of different organ systems.For optimal preservation of all the organ systems within the body, itwould be desirable to be able to selectively perfuse different organsystems with different perfusates, which have been optimized for each ofthe organ systems.

[0005] U.S. Pat. Nos. 5,308,320, 5,383,854, 5,820,593 and 5,879,316 byPeter Safar, S. William Stezoski and Miroslav Klain, describe acardiopulmonary bypass system capable of segmenting a patient's aortaand for selectively perfusing the different segments of the aorta withperfusates of different temperatures or chemical compositions. Other USpatents that address the concept of selective aortic perfusion includecommonly owned, copending patent applications; Ser. Nos. 08/909,293,filed Aug. 11, 1997; 08/909,380, filed Aug. 11, 1997, and 09/152,589filed Aug. 11, 1998 by Safar et al.; and U.S. Pat. No. 5,738,649 andcommonly owned copending patent application Ser. No. 09/060,412 filedApr. 14, 1998 by John A. Macoviak; and U.S. Pat. Nos. 5,827,237 and5,833,671 by John A. Macoviak and Michael Ross and commonly ownedcopending patent application Ser. No. 08/665,635, filed Jun. 17, 1996;filed Jun. 18, 1996, by John A. Macoviak and Michael Ross; and Ser. No.60/067,945, filed Dec. 8, 1997, by Bresnahan et al. These patentapplications and all other patents referred to herein are herebyincorporated by reference in their entirety. The balloon catheter ofSafar et al. may be introduced into the patient's aorta from aperipheral entry point, such as the femoral artery or the subclavianartery, or it may be introduced by a direct puncture in the patient'saorta during open chest surgery.

[0006] The previously described system, however, does not isolate thesegments of the circulatory system from one another on the venous sideof the circulatory system because the blood from each of the segmentsmingles together. Thus, any organ preserving temperature gradients,chemicals or therapeutic agents introduced into one of the segments willeventually mix with and be diluted into the entire systemic bloodsupply. In many circumstances it would be desirable to at leastpartially segment blood flow on the venous side of the circulatorysystem. For example, when administering anesthesia to a patient duringsurgery, it may be desirable to limit the flow of the anesthetic to thecerebral circulation only and to avoid dilution of the anesthetic in thesystemic blood supply, and even to recirculate the anesthetic to thecerebral circulation. As another example, when administering atherapeutic agent that is very costly or which has systemic, central orspecific organ toxicity or other undesirable effects, it may bedesirable to limit the flow of the therapeutic agent to the targetorgans as much as possible without it entering the systemic blood supplysuch as gene therapy, viral vectors protein plasmids and angiogenicgenes. As a third example, when performing segmented selective perfusioncombined with hypothermic organ preservation, it would be desirable toisolate the segments of the circulatory system on the venous side toallow more precise and efficient temperature control within eachcirculatory loop. It would be desirable, therefore, to provide acirculatory support system or cardiopulmonary bypass system that allowssegmentation of the circulatory system on the venous side, as well as onthe arterial side, for isolated closed loop circulatory support ofseparate organ systems. Such a closed loop circulatory support systemmay be used to supply the entire body with blood or other fluids througha plurality of isolated circulatory loops when the heart is not pumping.Alternatively, the closed loop circulatory support system may be used tocreate a single circulatory loop for supplying a single segment or organsystem of the body with blood or other fluids while the beating heartsupplies blood to the remainder of the body.

[0007] A plethora of known and newly discovered organ preservingchemicals and therapeutic agents are suitable for use with thecirculatory support system of the present invention. Among these arenatural and artificial blood substitutes or oxygen carriers, such asfree hemoglobin, PERFLUBRON, and perfluorocarbons, and hemoglobinmodifiers, such as RSR-13 (Allos Therapeutics), that increase oxygendelivery from blood to tissues. Also among these are neuroprotectiveagents, which have been the subject of intensive research in recentyears. Promising neuroprotective agents include Na⁺ blockers, glutamateinhibitors, nitric oxide inhibitors and radical scavengers. A thoroughtreatment of this subject can be found in the book NeuroprotectiveAgents, published by the New York Academy of Sciences. Possibletherapeutic agents include, inter alia, thrombolytic agents, such astPA, streptokinase and urokinase as well as gene therapy includingangiogenic genes.

SUMMARY OF THE INVENTION

[0008] The circulatory support system of the present invention generallyincludes one or more venous cannulae for draining blood from the venousside of the patient's circulatory system, one or more arterial cannulaefor perfusing the arterial side of the patient's circulatory system, andone or more blood circulation pumps connected between the venouscannulae and the arterial cannulae. The arterial cannulae and the venouscannulae of the circulatory support system may take one of severalpossible configurations. The circulatory support system is configured tosegment a patient's circulatory system into one or more isolatedcirculatory loops. The circulatory loops may be isolated from oneanother and/or from the remainder of the patient's circulatory system onthe venous side, as well as on the arterial side, for isolated closedloop circulatory support of separate organ systems. The circulatorysupport system of the present invention is suitable for use inminimally-invasive cardiac surgery, using thoracoscopic, port-access orminithoracotomy techniques, or for standard open-chest cardiac surgery.

[0009] Also disclosed is a method for circulatory support and forcardiopulmonary bypass using differential perfusion and/or isolatedsegmental perfusion of the circulatory system. According to the method,a patient's circulatory system is segmented into two or more regionsthat are perfused with perfusate at different temperatures and/ordifferent chemical compositions and/or different flow rates and/ordifferent pressures. The regions may be isolated from one another and/orfrom the remainder of the patient's circulatory system on the venousside, as well as on the arterial side, for isolated closed loopcirculatory support of separate organ systems.

[0010] In one variant of the method, a cerebral loop, a cardiac loop anda corporeal loop are created. A first fluid, preferably containingoxygenated blood, is circulated to the cerebral loop at a relatively lowtemperature of approximately 32° C. or lower for deep protectivehypothermia of the brain. Neuroprotective agents may be added to thefirst fluid to enhance the protection. A second fluid, which may includea cardioplegic agent, is circulated to the cardiac loop at a moderatetemperature between 32° C. and 37° C. for mild hypothermia of the heartto protect the myocardium, while avoiding arrhythmias that can be causedby deep hypothermia. A third fluid, preferably containing oxygenatedblood, is circulated to the corporeal loop at approximately 37° C. fornormothermic support of the remainder of the body. The venous side ofthe circulatory system may likewise be divided three ways so that thecerebral loop, cardiac loop and corporeal loop which are at leastpartially isolated from one another. Alternatively, the venous side ofthe circulatory system may be divided two ways so that the cardiac loopcombines with either the cerebral loop or corporeal loop on the venousside, or the flow from all three loops may be allowed to commingle onthe venous side of the circulatory system.

[0011] The use of differential perfusion according to this methodprovides several other clinical advantages in addition to thosediscussed above. The use of differing degrees of hypothermia allowsoptimal protection of the brain and of the heart during cardiopulmonarysupport, while decreasing the likelihood of complications. This methodreduces the thermal mass of the tissue that must be cooled and rewarmedduring the procedure. In addition, nornothermic corporeal circulationprovides a large reservoir of stored thermal energy for assisting inrewarming the heart and the brain at the end of the procedure. Both ofthese factors will result in decreasing the procedure time for surgeryrequiring cardiopulmonary bypass.

[0012] Still other clinical advantages exist with a closed loopcirculatory system of the present invention. By isolating the cerebral,myocardial and corporeal circulation on the venous side (outputs) aswell as the arterial side (inputs), isolated measurements in the aorticarch, aortic root, and corporeal circulation can be monitored inrelation to the superior vena cava, right atrium and inferior vena cavarespectively. This relationship will enable the clinician to determineoxygen saturation in the cerebral loop and in the corporeal loop tobetter manage the patient during the surgical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIG. 1 illustrates a side view of an aortic, catheter according tothe present invention with a catheter shaft configured for retrogradedeployment via femoral artery access.

[0014]FIG. 2 is a magnified lateral cross section of the aortic catheterof FIG. 1 taken along line 2-2 showing the multi-lumen arrangement ofthe catheter shaft.

[0015]FIG. 3 illustrates a side view of a superior vena cava cannulaaccording to the present invention with a tubular shaft configured forintroduction into a patient's venous system through the jugular vein orother peripheral artery.

[0016]FIG. 4 is a magnified lateral cross sectional of the superior venacava cannula of FIG. 3 taken along line 4-4 in FIG. 3.

[0017]FIG. 5 illustrates a side view of an inferior vena cava cannulaaccording to the present invention with a tubular shaft configured forintroduction into a patient's venous system through the femoral vein orother peripheral artery.

[0018]FIG. 6 is a magnified lateral cross sectional of the inferior venacava cannula of FIG. 5 taken along line 6-6 in FIG. 5.

[0019]FIG. 7 is a schematic illustration depicting a first embodiment ofthe present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system.

[0020]FIG. 8 is a cutaway close-up view of the cannula placement asshown in FIG. 7 with a portion of the patient's heart cut away to bettershow the descending aorta.

[0021]FIG. 9 illustrates a side view of an aortic catheter according tothe present invention with a catheter shaft configured for retrogradedeployment via femoral artery access.

[0022]FIG. 10 is a magnified lateral cross section of the aorticcatheter of FIG. 9 taken along line 10-10 showing the multi-lumenarrangement of the catheter shaft.

[0023]FIG. 11 illustrates a side view of a dual lumen venous drainagecannula of the present invention configured for introduction through thepatient's inferior vena cava via the femoral vein or other suitablevenous access point in the lower extremities.

[0024]FIG. 12 is a magnified lateral cross section of the venousdrainage cannula taken along line 12-12 of FIG. 11.

[0025]FIG. 13 is a magnified lateral cross section of the venousdrainage cannula taken along line 13-13 of FIG. 11.

[0026]FIG. 14 is a schematic illustration depicting a second embodimentof the present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system.

[0027]FIG. 15 is a cutaway close-up view of the cannula placement asshown in FIG. 14 with a portion of the patient's heart cut away tobetter show the descending aorta.

[0028]FIG. 16 illustrates a side view of an aortic catheter according tothe present invention with a coaxial catheter shaft configured forretrograde deployment via femoral artery access.

[0029]FIG. 17 is a magnified lateral cross section of the aorticcatheter of FIG. 16 taken along line 17-17 showing the multi-lumencoaxial arrangement of the catheter shaft.

[0030]FIG. 18 is a magnified lateral cross-section of the aorticcatheter of FIG. 16 taken along line 18-18 showing the multi-lumenarrangement of the catheter shaft.

[0031]FIG. 19 illustrates a side view of a coaxial dual lumen venousdrainage cannula of the present invention configured for introductionthrough the patient's inferior vena cava via the femoral vein or othersuitable venous access point in the lower extremities.

[0032]FIG. 20 is a magnified lateral cross section of the coaxial duallumen venous drainage cannula taken along line 20-20 of FIG. 19.

[0033]FIG. 21 is a magnified lateral cross section of the coaxial duallumen venous drainage cannula taken along line 21-21 of FIG. 19.

[0034]FIG. 22 illustrates a third embodiment of the support system ofthe present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system.

[0035]FIG. 23 is a cutaway close-up view of the cannula placement ofFIG. 22 with a portion of the patient's heart cut away to better showthe descending aorta.

[0036]FIG. 24 illustrates an aortic arch perfusion cannula of thepresent invention configured for introduction into the aortic archthrough peripheral arterial access in one of the upper extremities, suchas the left or right subclavian artery, axillary artery or brachialartery.

[0037]FIG. 25 is a magnified lateral cross section of the aortic archperfusion cannula of FIG. 24 taken along line 25-25 of FIG. 24 showingthe multi-lumen arrangement of the catheter shaft.

[0038]FIG. 26 illustrates a corporeal perfusion cannula of the presentinvention configured for introduction into the descending aorta througha peripheral arterial access in one of the lower extremities, such asthe femoral artery.

[0039]FIG. 27 is a magnified lateral cross section of the corporealperfusion cannula taken along line 27-27 of FIG. 26 showing themulti-lumen arrangement of the catheter shaft.

[0040]FIG. 28 illustrates a fourth embodiment of the support system ofthe present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system.

[0041]FIG. 29 illustrates a side view of a dual-balloon, selective,central arterial perfusion cannula configured for antegrade introductioninto the patient's aortic arch via a direct puncture or incision in theascending aorta.

[0042]FIG. 30 is a magnified lateral cross section of the aorticcatheter of FIG. 29 taken along line 30-30 in FIG. 29 illustrating themulti-lumen arrangement of the aortic catheter.

[0043]FIG. 31 illustrates a side view of the central superior vena cavacannula of the present invention configured for introduction into thepatient's superior vena cava via an incision in the right atrium.

[0044]FIG. 32 is a magnified lateral cross-section of the centralsuperior vena cava cannula taken along line 32-32 of FIG. 31.

[0045]FIG. 33 illustrates a side view of the central inferior vena cavacannula of the present invention configured for introduction into thepatient's inferior vena cava through the same or another incision in theright atrium.

[0046]FIG. 34 is a magnified lateral cross-section of the centralsuperior vena cava cannula taken along line 33-33 of FIG. 33.

[0047]FIG. 35 is a schematic diagram of a fifth embodiment of thecirculatory support system of the present invention configured forselective, isolated, dual loop perfusion of a patient's circulatorysystem.

[0048]FIG. 36 is a side view of an aortic perfusion shunt apparatusconfigured for insertion into a patient's aorta via a peripheral arterysuch as the femoral artery.

[0049]FIG. 37 is a distal end view of the expandable shunt conduit ofthe aortic perfusion shunt apparatus of FIG. 36 taken along line 37-37.

[0050]FIG. 38 shows a schematic diagram of a sixth embodiment of thecirculatory support system of the present invention configured forselective, closed-loop perfusion of a patient's cerebral circulation andupper extremities, while the beating heart supplies the viscera andlower extremities with blood.

[0051]FIG. 39 shows a schematic diagram of a seventh embodiment of thecirculatory support system of the present invention configured forselective, closed-loop perfusion of a patient's renal system, while thebeating heart supplies the remainder of the circulatory system withblood.

DETAILED DESCRIPTION OF THE INVENTION

[0052] The circulatory support system of the present invention generallycomprises one or more arterial cannulae to enable the segmentedperfusion of the patient's circulatory system. On the arterial side, oneor more venous cannulae for enable segmented draining of the patient'scirculatory system on the venous side, and one or more blood circulationpumps connect between the venous cannulae and the arterial cannulae.Preferably, the circulatory support system will also include one or moreblood oxygenators and one or more heat exchangers for conditioning thepatient's blood. The circulatory support system is configured to segmenta patient's circulatory system into one or more isolated circulatoryloops. The circulatory loops are isolated from one another and/or fromthe remainder of the patient's circulatory system on the venous side, aswell as on the arterial side, for isolated closed loop circulatorysupport of separate organ systems.

[0053]FIGS. 1 through 7 illustrate a first embodiment of the presentinvention. FIG. 1 illustrates a side view of the aortic catheter 100according to the present invention with a catheter shaft 102 configuredfor retrograde deployment via femoral artery access. In order tofacilitate placement of the aortic catheter 100 and to improve thestability of the catheter 100 in the proper position in the patient'saorta, a distal region 144 of the catheter shaft 102 may be preshapedwith a curve to match the internal curvature of the patient's aorticarch. The curved distal region 144 represents a J-shaped curve ofapproximately 180 degrees of arc with a radius of curvature ofapproximately 2 to 4 cm to match the typical curvature of the aorticarch in an adult human patient. In addition, the distal end 106 of thecatheter may be skewed slightly up out of the plane of the curve toaccommodate the forward angulation of the patient's ascending aorta.Additionally, the catheter shaft 102 may be reinforced, particularly inthe curved distal region 144, for example with braided or coiled wire,to further improve the stability of the catheter 100 in the properposition in the patient's aorta.

[0054] Illustrated in FIG. 2, is a magnified lateral cross section ofthe aortic catheter 100 of FIG. 1 taken along line 2-2 showing themulti-lumen arrangement of the catheter shaft 102. The catheter shaft102 has six lumens: a corporeal perfusion lumen 108, an arch perfusionlumen 110, a first balloon inflation lumen 112, a second ballooninflation lumen 114, a guide wire and cardioplegia lumen 116 and a rootpressure lumen 118.

[0055] Referring to FIG. 1 the elongated catheter shaft 102 ispreferably formed of a flexible thermoplastic material, a thermoplasticelastomer or a thermoset elastomer. The catheter shaft 102 may befabricated separately by known extrusion methods and joined togetherend-to-end, for example by heat welding or by adhesive bonding.Alternatively, the catheter shaft 102 may be fabricated by dipping or bycomposite construction techniques and joined together or the entirecatheter shaft 102 may be fabricated integrally. Suitable materials forthe elongated catheter shaft 102 include, but are not limited to,polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides(nylons), polyesters, silicone, latex, and alloys or copolymers thereof,as well as braided, coiled or counterwound wire or filament reinforcedcomposites.

[0056] An upstream occlusion member 120 is mounted on the catheter shaft102 near the distal end 106 of the catheter 100. The upstream occlusionmember 120 in this embodiment is in the form of an expandable,inflatable balloon bonded to the catheter shaft 102 by heat welding orwith an adhesive. Alternatively, the upstream occlusion member 120 maybe in the form of a selectively deployable external catheter valve. Fora discussion of other suitable upstream occlusion members as well as thematerial components thereof, reference is made to commonly owned U.S.Pat. Nos. 5,827,237, and 5,833,671 which have previously beenincorporated by reference herein in their entirety and commonly ownedcopending patent application Ser. No. 09/205,753 filed Dec. 4, 1998,which is herein incorporated by reference. These occlusion membersdiscussed therein are suitable for all embodiments discussed herein inany combination. Suitable materials for the upstream occlusion member120 include flexible polymers and elastomers, which include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, latex, silicone, andalloys, copolymers and reinforced composites thereof. In addition, theouter surface of the upstream occlusion member 120 may include afriction increasing coating or texture to increase friction with theaortic wall when deployed. The upstream occlusion member 120 has adeflated state, in which the diameter of the occlusion member 120 ispreferably not much larger than the diameter of the catheter shaft 102,and an inflated state, in which the occlusion member 120 expands to adiameter sufficient to occlude blood flow in the ascending aorta of thepatient. For use in adult human patients, the inflatable balloonupstream occlusion member 120 preferably has an inflated outer diameterof approximately 1.5 cm to 5.0 cm. Preferably, the inflatable occlusionmember 120 has an inflated length that is not significantly longer thanits inflated diameter, or, more preferably, is shorter than its inflateddiameter. This shortened inflated profile allows the upstream occlusionmember 120 to be easily placed within the ascending aorta between thecoronary arteries and the brachiocephalic artery without any danger ofinadvertently occluding either.

[0057] A downstream occlusion member 122 is mounted on the cathetershaft 102 at a position proximal to and spaced apart from the upstreamocclusion member 120. The downstream anchoring member may be made of thesame materials as the upstream anchoring member of different materialsand of the same size or a different size. For a complete discussion onthe potential sizes and characteristics of the downstream occlusionmember, reference is made to commonly owned copending patent applicationSer. No. 09/205,753 filed Dec. 4, 1998 which has previously beenincorporated by reference. The downstream anchoring members discussedtherein are suitable for all embodiments discussed herein in anycombination. The distance between the upstream occlusion member 120 andthe downstream occlusion member 122 is preferably between 3 and 20 cm,more preferably between 8 and 15 cm, and is chosen so that when theaortic catheter 100 is deployed and the upstream occlusion member 120 ispositioned within the ascending aorta between the coronary arteries andthe brachiocephalic artery, the downstream occlusion member 122 will bepositioned in the descending aorta downstream of the left subclavianartery. The downstream occlusion member 122 in this embodiment is in theform of an expandable, inflatable balloon bonded to the catheter shaft102 by heat welding or with an adhesive. The downstream occlusion member122 is more elongated, than the upstream occlusion member 120. Suitablematerials for the inflatable balloon downstream anchoring member 122include flexible polymers and elastomers, which include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, latex, silicone, andalloys, copolymers and reinforced composites thereof In addition, theouter surface of the downstream anchoring member 122 may include afriction increasing coating or texture to increase friction with theaortic wall when deployed. Alternatively, the downstream occlusionmember 122 may be in the form of a selectively deployable valve.

[0058] The inflatable downstream occlusion member 122 has a deflatedstate, in which the diameter of the occlusion member 122 is preferablynot much larger than the diameter of the catheter shaft 102, and aninflated state, in which the occlusion member 122 expands to a diametersufficient to occlude blood flow in the descending aorta of the patient.For use in adult human patients, the downstream occlusion member 122preferably has an inflated outer diameter of approximately 1.5 cm to 5.0cm and a length of approximately 1.0 cm to 7.5 cm. The more elongatedthe occlusion member 122 the greater the anchoring friction against thewall of the descending aorta when the downstream occlusion member 122 isinflated in order to prevent migration of the aortic catheter 100 due topressure gradients within the aorta during perfusion.

[0059] The corporeal perfusion lumen 108 extends through the cathetershaft 102 from the proximal end 104 to one or more corporeal perfusionports 124 on the exterior of the catheter shaft 102 proximal of thedownstream occlusion member 122. The arch perfusion lumen 110 extendsthrough the catheter shaft 102 from the proximal end 104 to one or morearch perfusion ports 126 on the exterior of the catheter shaft 102between the upstream occlusion member 120 and the downstream occlusionmember 122. The first inflation lumen 112 extends through the cathetershaft 102 from the proximal end 104 to a first balloon inflation port132 residing in the interior of the downstream occlusion member 122. Thesecond balloon inflation lumen 114 extends through the catheter shaft102 from the proximal end 104 to balloon inflation port 130 residing inthe interior of the upstream occlusion member 120. Alternatively, acommon balloon inflation lumen can serve to simultaneously inflate anddeflate both the upstream occlusion member 120 and the downstreamocclusion member 122. When a common inflation lumen is implemented anarch monitoring lumen (not shown) may be incorporated having an archmonitoring port residing between the upstream occlusion member 120 andthe downstream occlusion member 122 to monitor the pressure in theaortic arch.

[0060] The root pressure lumen 118 extends through the catheter shaft102 from the proximal end 104 to a root pressure port 128 near thedistal end 106 of the catheter shaft 102 to monitor pressure in theaortic root. The guide wire and cardioplegia lumen 116 extends from theproximal end 104 of the catheter shaft 102 to a guide wire/cardioplegiaport 136 at the distal end 106 of the catheter shaft 102, distal to theupstream occlusion member 120. Preferably, the distal end 106 of thecatheter shaft 102 is smoothly tapered or rounded for easy introductionand to avoid trauma or injury to the aortic wall during insertion orwithdrawal of the aortic catheter 100.

[0061] Preferably, the aortic catheter 100 includes one or more markers,which may include radiopaque markers and/or sonoreflective markers, toenhance imaging of the aortic catheter 100 using fluoroscopy orultrasound, such as transesophageal echocardiography (TEE). In thisillustrative embodiment, the aortic catheter 100 includes a distalradiopaque marker 138 positioned near the distal end 106 of the cathetershaft 102, an intermediate radiopaque marker 140 positioned near theproximal edge of the upstream occlusion member 120, and a proximalradiopaque marker 142 positioned near the distal edge of the downstreamanchoring member 122. Each of the radiopaque markers 138, 140, 142 maybe made of a ring of dense radiopaque metal, such as gold, platinum,tantalum, tungsten or alloys thereof, or a ring of a polymer or adhesivematerial heavily loaded with a radiopaque filler material.

[0062] The proximal end 104 of the catheter shaft 102 is connected to amanifold 150 with fittings for each of the catheter lumens. Thecorporeal perfusion lumen 108 is connected to a Y-fitting 162 that has abarb connector 152 for connection to a perfusion pump or the like and aluer connector 154, which may be used for monitoring perfusion pressure,for withdrawing fluid samples or for injecting medications or otherfluids. Likewise, the arch perfusion lumen 110 is connected to aY-fitting 164 that has a barb connector 156 for connection to aperfusion pump and a luer connector 158. The balloon inflation lumens112 and 114 are connected to luer connectors 160 and 166 respectively orother fittings suitable for connection to a syringe or balloon inflationdevice. The guide wire and cardioplegia lumen 116 is connected to athree-way Y-fitting 170 that has a barb connector 172 for connection toa cardioplegia infusion pump, a luer connector 174 and a guide wire port176 with a Touhy-Borst adapter or other hemostasis valve. The rootpressure lumen 118 is connected to a luer connector 168 or other fittingsuitable for connection to a pressure monitor.

[0063]FIG. 3 illustrates a side view of a superior vena cava cannula 399according to the present invention with a tubular shaft 398 configuredfor introduction into a patient's venous system through the jugular veinor other peripheral artery. FIG. 4 is a magnified lateral crosssectional of the superior vena cava cannula 399 of FIG. 3 taken alongline 4-4 in FIG. 3.

[0064] Referring now to FIGS. 3 and 4 collectively, the superior venacava cannula 399 has a tubular shaft 398 that includes a venous drainagelumen 397 and a balloon inflation lumen 396. The tubular shaft 398preferably has a length of approximately 15 cm to 60 cm and a diameterof approximately 10 to 32 French (3.3 mm to 10.7 mm diameter). Anocclusion balloon 395 or other expandable occlusion member is mounted onthe tubular shaft 398 near the distal end of the cannula 399. Theocclusion balloon 395 or other expandable occlusion member preferablyhas an expanded diameter of approximately 5 mm to 40 mm. The venousdrainage lumen 397 extends through the tubular shaft 398 from a venousdrainage fitting 394 to one or more venous drainage ports 393 on thetubular shaft 398 proximal to the occlusion balloon 395. The venousdrainage fitting has a luer connector 373 which may be used formonitoring pressure, temperature, chemical compositions and forwithdrawing fluid samples or for injecting medications or other fluids,a barb connector 372 or other suitable fitting for being connected to aCPB machine and a guide wire entry connector 392 in the form of aThouy-Borst fitting or other suitable hemostasis valve for creating afluid tight seal when using a guide wire. When a guide wire is used thevenous drainage lumen 397 serves as an additional guide wire lumencapable of receiving a guide wire 301 which is guided to a guide wireport 374 on the end of the tubular shaft 398 distal to the occlusionballoon 395. Alternatively, a separate lumen may be provided leading toa port distal to the occlusion balloon 395 wherein a separate monitoringdevice may be slidably or integrally disposed to give monitoringinformation inside or outside the cannula 399, and inside the superiorvena cava. The balloon inflation lumen 396 extends through the tubularshaft 398 from a balloon inflation fitting 391 on the proximal end ofthe cannula 399 to one or more balloon inflation ports 390 within theocclusion member 395.

[0065]FIG. 5 illustrates a side view of an inferior vena cava cannula589 according to the present invention with a tubular shaft 588configured for introduction into a patient's venous system through thefemoral or other peripheral artery. FIG. 6 is a magnified lateral crosssectional of the inferior vena cava cannula 589 of FIG. 5 taken alongline 6-6 in FIG. 5.

[0066] Referring collectively to FIGS. 5 and 6, the inferior vena cavacannula 589 is configured for introduction into the patient's inferiorvena cava via the femoral vein or other suitable venous access point inthe lower extremities. The inferior vena cava cannula 589 has a tubularshaft 588 that includes a venous drainage lumen 587 and a ballooninflation lumen 586. The tubular shaft 588 preferably has a length ofapproximately 15 cm to 90 cm and a diameter of approximately 10 to 32French (3.3 mm to 10.7 mm diameter). An occlusion balloon 585 or otherexpandable occlusion member is mounted on the tubular shaft 588 near thedistal end of the cannula 589. The occlusion balloon 585 or otherexpandable occlusion member preferably has an expanded diameter ofapproximately 5 mm to 40 mm. The venous drainage lumen 587 extendsthrough the tubular shaft 588 from a venous drainage fitting 584 on theproximal end of the cannula shaft 588 to one or more venous drainageports 583 on the tubular shaft 588 proximal to the occlusion balloon585. The venous drainage fitting 584 has a luer connector 563 which maybe used for monitoring pressure, temperature, chemical compositions andfor withdrawing fluid samples or for injecting medications or otherfluids, a barb connector 562 or other suitable fitting for beingconnected to a CPB machine and a guide wire entry connector 582 in theform of a Thouy-Borst fitting or other suitable hemostasis valve forcreating a fluid tight seal when using a guide wire. When a guide-wireis used the venous drainage lumen 587 serves as an additional guide wirelumen configured for receiving a guide wire 501 which is guided to aguide wire port 564 on the end of the tubular shaft 588 distal to theocclusion balloon 585. Alternatively, a separate lumen may be providedleading to a port distal to the occlusion balloon 585 wherein a separatemonitoring device integral or nonintegral is slideably disposed to givemonitoring information inside or outside the cannula 589, and inside theinferior vena cava. The balloon inflation lumen 586 extends through thetubular shaft 588 from a balloon inflation fitting 581 on the proximalend of the cannula 589 to one or more balloon inflation ports 580 withinthe occlusion balloon 585.

[0067]FIG. 7 is a schematic illustration depicting a first embodiment ofthe present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system. The circulatory supportsystem has a cerebral loop for perfusion of the patient's cerebralcirculation and upper extremities and a separate corporeal loop forperfusion of the patient's viscera and lower extremities. Optionally,the patient's coronary circulation may be included in the cerebral loopor the corporeal loop or a third, isolated coronary loop may be created.In this embodiment of the circulatory support system, arterialcannulation is provided by a dualballoon, selective arterial perfusioncannula 700, and venous cannulation is provided by a superior vena cavacannula 799 and a separate inferior vena cava cannula 788. FIG. 8 is acutaway close-up view of the cannula placement as shown in FIG. 7 with aportion of the patient's heart cut away to better show the descendingaorta.

[0068] Referring now to FIGS. 7 and 8, the cerebral closed loopcirculation is created by having venous drainage port 793 proximal tothe occlusion balloon 795 in fluid communication with the venousdrainage lumen 797. Connected to the venous drainage lumen 797 of thesuperior vena cava cannula 799 is a venous drainage fitting 794 which isconnected to inflow tubing 777 in fluid communication with inflow port751 of a first blood circulation pump 750. After the blood isconditioned it is pumped through outflow port 753 which is coupled tooutflow tubing 754 in fluid communication with barb connector 756 whichis coupled to the arch perfusion lumen 710 of the arterial cannula 700.The first blood circulation pump 750 may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump. Forillustrative purposes a membrane oxygenator system is provided for thecerebral circulation and a bubble oxygenator is provided for thecorporeal circulation. It is understood by those skilled in the art thateither oxygenator may be employed. In addition, a system may use twobubble oxygenators, two membrane oxygenators or a membrane oxygenatorand a bubble oxygenator or any combination thereof. This illustrativeembodiment and all others contained herein may be configured with anycombination as so stated.

[0069] The cerebral loop of the circulatory support system includes avenous drainage cannula 799, which drains to a venous blood reservoir701, the blood is pumped to a heat exchanger 702 and membrane oxygenator703 in series with the first blood circulation pump. Optionally, vacuumassist (not shown) may be used to enhance venous drainage through thesuperior vena cava cannula 799. Venous blood from the head and upperextremities enters the patient's superior vena cava and is drained outthrough the venous drainage lumen 797 of the superior vena cava cannula799. The blood is oxygenated, cooled and recirculated by the first bloodcirculation pump 757 to the head and upper extremities through the archperfusion lumen 710 and out the arch perfusion ports 726 within thearterial cannula 700.

[0070] The corporeal loop of the circulatory support system includes avenous drainage cannula 789, which drains into a combined heat exchangebubble oxygenator to an arterial reservoir where it is pumped toarterial cannula 700. The venous drainage lumen 787 is fluidcommunication with drainage port 783 proximal to the occlusion balloon785 in fluid communication with the venous drainage lumen 787.Alternatively there can be a venous drainage port 730 distal as well asproximal to the occlusion balloon 785. Connected to the venous drainagelumen 787 of the inferior vena cava cannula 789 has a venous drainagefitting 784 connected to corporeal inflow tubing 749 in fluidcommunication with inflow port 748 of the second blood circulation pump747. After the blood is conditioned it is pumped through outflow port746 which is coupled to outflow tubing 745 in fluid communication withbarb connector 752 which is coupled to the corporeal perfusion lumen 708of the arterial cannula 700. The second blood circulation pump 747 maybe a peristaltic roller pump, a centrifugal blood pump or other suitableblood circulation pump. The corporeal loop of the circulatory supportsystem includes a venous blood reservoir 706, a blood oxygenator 705 andheat exchanger 704 in series with the second blood circulation pump.Optionally, vacuum assist (not shown) may be used to enhance venousdrainage through the inferior vena cava cannula 789. Venous blood fromthe viscera and lower extremities enters the patient's inferior venacava and is drained out through the venous drainage lumen 787 of theinferior vena cava cannula 789. The blood is oxygenated, cooled andrecirculated by the second blood circulation pump 747 to the viscera andlower extremities through the corporeal perfusion lumen 708 and out thecorporeal perfusion ports 724 of the arterial cannula 700.

[0071] Optionally, either the superior vena cava cannula 799 or theinferior vena cava cannula 789 may be made without the occlusion balloonor with additional drainage ports distal to the balloon so that thecannula drains the patient's right atrium and the coronary sinus as partof the cerebral loop or the corporeal loop, respectively. Alternatively,either the superior vena cava cannula 799 or the inferior vena cavacannula 789 can be made with a separate, second drainage lumen connectedto drainage ports positioned distal to the balloon for draining thepatient's right atrium and the coronary sinus. A separate coronaryperfusion loop can be created by connecting the second drainage lumen tothe inflow of a third blood circulation pump and connecting the outflowof the pump to the cardioplegia lumen of the arterial cannula 700. Thethird blood circulation pump may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump.Preferably, the coronary loop also includes a venous blood reservoir, ablood oxygenator and heat exchanger in series with the third bloodcirculation pump.

[0072] As another alternative, the coronary circulation can be isolatedby using a coronary sinus catheter for retrograde administration ofcardioplegia into the patient's coronary arteries. This would eliminatethe need for the occlusion balloon on either the superior vena cavacannula 799 or the inferior vena cava cannula 789 and the patient'sright atrium could be drained as part of the cerebral loop or thecorporeal loop. For example, a superior vena cava cannula 799 without anocclusion balloon (not shown) or with the balloon deflated (not shown)could be inserted into the superior vena cava and the right atrium viathe jugular vein. An inferior vena cava cannula 789 would be insertedinto the inferior vena cava via the femoral vein and the occlusionballoon 785 inflated to isolate the corporeal loop. A coronary sinuscatheter can be inserted collaterally with the superior vena cavacannula 799 via the jugular vein to isolate the coronary circulation onthe venous side and for antegrade or retrograde flow of blood,cardioplegia or other fluids. Suitable coronary sinus catheter forretrograde administration of cardioplegia can be found in U.S. Pat. Nos.5,738,652; 5,722,963; 5,720,726; 5,662,607; 5,653,690; 5,643,231;5,620,418; 5,617,854; 5,597,377; 5,558,644; 5,549,581; 5,533,957;5,505,698; 5,488,960; 5,487,730; 5,466,216; 5,423,772; 5,423,745;5,401,244; 5,395,331; 5,385,548; 5,385,540; 5,324,260; 5,197,952;5,024,668; 5,021,045; 4,943,277; 4,927,412; 4,753,637; 4,648,384;4,459,977, which are hereby incorporated by reference in their entirety.

[0073] To complete the closed loop circulation system an arterialperfusion cannula 700 is provided. The dual-balloon, selective arterialperfusion cannula 700 is configured for retrograde introduction into thepatient's aorta via a peripheral arterial access point, such as thefemoral artery. The dual-balloon, selective arterial perfusion cannula700 has a tubular shaft 702 that includes a corporeal perfusion lumen708, an arch perfusion lumen 710, a guide wire cardioplegia lumen 716,two balloon inflation lumens 712 and 714 and, a root pressure lumen 718.An upstream occlusion balloon 720 or other expandable occlusion memberis mounted on the tubular shaft 702 so that it is positioned in theascending aorta between the coronary arteries and the rightbrachiocephalic artery. A downstream occlusion balloon 722 or otherexpandable occlusion member is mounted on the tubular shaft 702 so thatit is positioned in the descending aorta downstream of the leftsubclavian artery. The corporeal perfusion lumen 708 extends through thetubular shaft 702 from a corporeal barb connector 752 to one or morecorporeal perfusion ports 724 on the tubular shaft 702 proximal to thedownstream occlusion balloon 722. The arch perfusion lumen 710 extendsthrough the tubular shaft 702 from an arch barb connector 756 to one ormore arch perfusion ports 726 on the tubular shaft 702 between theupstream occlusion balloon 720 and the downstream occlusion balloon 722.The guide wire cardioplegia lumen 716 extends through the tubular shaft702 from a barb connector 772 to one or more cardioplegia ports 736 onthe tubular shaft distal to the upstream occlusion balloon 720. The rootpressure lumen 718 extends through the tubular shaft 702 from a pressurefitting 768 to a root pressure port 728 on the tubular shaft 702 distalto the upstream occlusion balloon 720. A first balloon inflation lumen712 extends through the tubular shaft 702 a balloon inflation fitting760 a balloon inflation port 732 within the downstream occlusion balloon722. A second balloon inflation lumen 714 extends through the tubularshaft 702 to a balloon inflation fitting 766 to a balloon inflation port730 within the upstream occlusion balloon 720. FIGS. 9 through 15illustrate a second embodiment of the circulatory support system of thepresent invention, which is also configured for selective, isolated,dual-loop perfusion of a patient's circulatory system. The circulatorysupport system has a cerebral loop for perfusion of the patient'scerebral circulation and upper extremities and a separate corporeal loopfor perfusion of the patient's viscera and lower extremities. As in thepreviously described embodiment, the patient's coronary circulation mayoptionally be included in the cerebral loop or the corporeal loop or athird, isolated coronary loop may be created. In this embodiment of thecirculatory support system, arterial cannulation is provided by adualballoon, selective arterial perfusion cannula 900 similar to the onepreviously described in connection with FIG. 1 and venous cannulation isprovided by a dual-lumen venous drainage cannula 1199.

[0074]FIG. 9 illustrates a side view of the aortic catheter 900according to the present invention with a catheter shaft 902 configuredfor retrograde deployment via femoral artery access. In order tofacilitate placement of the aortic catheter 900 and to improve thestability of the catheter 900 in the proper position in the patient'saorta, a distal region 944 of the catheter shaft 902 may be preshapedwith a curve to match the internal curvature of the patient's aorticarch. The curved distal region 944 represents a J-shaped curve ofapproximately 180 degrees of arc with a radius of curvature ofapproximately 2 to 4 cm to match the typical curvature of the aorticarch in an adult human patient. In addition, the distal end 906 of thecatheter may be skewed slightly up out of the plane of the curve toaccommodate the forward angulation of the patient's ascending aorta.Additionally, the catheter shaft 902 may be reinforced, particularly inthe curved distal region 944, for example with braided or coiled wire,to further improve the stability of the catheter 900 in the properposition in the patient's aorta.

[0075] Illustrated in FIG. 10, is a magnified lateral cross section ofthe aortic catheter 900 of FIG. 9 taken along line 10-10 showing themulti-lumen arrangement of the catheter shaft 902. The catheter shaft902 has six lumens: a corporeal perfusion lumen 908, an arch perfusionlumen 910, a common balloon inflation lumen 912, an arch monitoringlumen 914, a guide wire and cardioplegia lumen 916 and a root pressurelumen 918.

[0076] Referring to FIG. 9 the elongated catheter shaft 902 ispreferably formed of a flexible thermoplastic material, a thermoplasticelastomer or a thermoset elastomer. The catheter shaft 902 may befabricated separately by known extrusion methods and joined togetherend-to-end, for example by heat welding or by adhesive bonding.Alternatively, the catheter shaft 902 may be fabricated by dipping or bycomposite construction techniques and joined together or the entirecatheter shaft 902 may be fabricated integrally. Suitable materials forthe elongated catheter shaft 902 include, but are not limited to,polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides(nylons), polyesters, silicone, latex, and alloys or copolymers thereof,as well as braided, coiled or counterwound wire or filament reinforcedcomposites.

[0077] An upstream occlusion member 920 is mounted on the catheter shaft902 near the distal end 906 of the catheter 900. The upstream occlusionmember 920 in this embodiment is in the form of an expandable,inflatable balloon bonded to the catheter shaft 902 by heat welding orwith an adhesive. Suitable materials for the upstream occlusion member920 include flexible polymers and elastomers, which include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, latex, silicone, andalloys, copolymers and reinforced composites thereof. In addition, theouter surface of the upstream occlusion member 920 may include afriction increasing coating or texture to increase friction with theaortic wall when deployed. The upstream occlusion member 920 has adeflated state, in which the diameter of the occlusion member 920 ispreferably not much larger than the diameter of the catheter shaft 902,and an inflated state, in which the occlusion member 920 expands to adiameter sufficient to occlude blood flow in the ascending aorta of thepatient. For use in adult human patients, the inflatable balloonupstream occlusion member 920 preferably has an inflated outer diameterof approximately 1.5 cm to 5.0 cm. Preferably, the inflatable occlusionmember 920 has an inflated length that is not significantly longer thanits inflated diameter, or, more preferably, is shorter than its inflateddiameter. This shortened inflated profile allows the upstream occlusionmember 920 to be easily placed within the ascending aorta between thecoronary arteries and the brachiocephalic artery without any danger ofinadvertently occluding either.

[0078] A downstream occlusion member 922 is mounted on the cathetershaft 902 at a position proximal to and spaced apart from the upstreamocclusion member 920. The distance between the upstream occlusion member920 and the downstream occlusion member 922 is preferably between 3 and20 cm, more preferably between 8 and 15 cm, and is chosen so that whenthe aortic catheter 900 is deployed and the upstream occlusion member920 is positioned within the ascending aorta between the coronaryarteries and the brachiocephalic artery, the downstream anchoring member922 will be positioned in the descending aorta downstream of the leftsubclavian artery. The downstream occlusion member 922 in thisembodiment is in the form of an expandable, inflatable balloon bonded tothe catheter shaft 902 by heat welding or with an adhesive. Thedownstream occlusion member 922 is may be larger, that is to say, moreelongated, than the upstream occlusion member 920 of the same size orsmaller. Suitable materials for the inflatable balloon downstreamanchoring member 922 include flexible polymers and elastomers, whichinclude, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Inaddition, the outer surface of the downstream anchoring member 922 mayinclude a friction increasing coating or texture to increase frictionwith the aortic wall when deployed.

[0079] The inflatable downstream occlusion member 922 has a deflatedstate, in which the diameter of the occlusion member 922 is preferablynot much larger than the diameter of the catheter shaft 902, and aninflated state, in which the occlusion member 922 expands to a diametersufficient to substantially prohibit blood flow in the descending aortaof the patient. For use in adult human patients, the downstreamocclusion member 922 preferably has an inflated outer diameter ofapproximately 1.0 cm to 5.0 cm and a length of approximately 1.0 cm to7.5 cm. The more elongated the occlusion member 922 the greater theanchoring friction against the wall of the descending aorta when thedownstream occlusion member 922 is inflated in order to preventmigration of the aortic catheter 900 due to pressure gradients withinthe aorta during perfusion.

[0080] The corporeal perfusion lumen 908 extends through the cathetershaft 902 from the proximal end 904 to one or more corporeal perfusionports 924 on the exterior of the catheter shaft 902 proximal of thedownstream occlusion member 922. Alternatively, to simplify catheterdesign and to reduce overall catheter diameter a separate contralateral,or co-lateral peripheral access arterial cannula may be used to accesseither the same femoral artery or the other femoral artery. The archperfusion lumen 910 extends through the catheter shaft 902 from theproximal end 904 to one or more arch perfusion ports 926 on the exteriorof the catheter shaft 902 between the upstream occlusion member 920 andthe downstream occlusion member 922. A common balloon inflation lumen912 extends through the catheter shaft 902 from the proximal end 904 toballoon inflation ports 932 and 930 which reside in the interior ofdownstream occlusion balloon 922 and the upstream occlusion balloon 920respectively. Alternatively, separate inflation lumens can beimplemented to separately inflate the downstream occlusion member 922and the upstream occlusion member 920.

[0081] The arch monitoring lumen 914 extends through the catheter shaft902 from the proximal end 904 to an arch monitoring port 934 proximal tothe upstream occlusion member 920 to monitor pressure in the aorticroot. The root pressure lumen 918 extends through the catheter shaft 902from the proximal end 904 to a root pressure port 928 near the distalend 906 of the catheter shaft 902 to monitor pressure in the aorticroot. The guide wire and cardioplegia lumen 916 extends from theproximal end 904 of the catheter shaft 902 to a guide wire/cardioplegiaport 936 at the distal end 906 of the catheter shaft 902, distal to theupstream occlusion member 920. Preferably, the distal end 906 of thecatheter shaft 902 is smoothly tapered or rounded for easy introductionand to avoid trauma or injury to the aortic wall during insertion orwithdrawal of the aortic catheter 900.

[0082] Preferably, the aortic catheter 900 includes one or more markers,which may include radiopaque markers and/or sonoreflective markers, toenhance imaging of the aortic catheter 900 using fluoroscopy orultrasound, such as transesophageal echocardiography (TEE). In thisillustrative embodiment, the aortic catheter 900 includes a distalradiopaque marker 938 positioned near the distal end 906 of the cathetershaft 902, an intermediate radiopaque marker 940 positioned near theproximal edge of the upstream occlusion member 920, and a proximalradiopaque marker 942 positioned near the distal edge of the downstreamanchoring member 922. Each of the radiopaque markers 938, 940, 942 maybe made of a ring of dense radiopaque metal, such as gold, platinum,tantalum, tungsten or alloys thereof, or a ring of a polymer or adhesivematerial heavily loaded with a radiopaque filler material.

[0083] The proximal end 904 of the catheter shaft 902 is connected to amanifold 950 with fittings for each of the catheter lumens. Thecorporeal perfusion lumen 908 is connected to a Y-fitting 962 that has abarb connector 952 for connection to a perfusion pump or the like and aluer connector 954, which may be used for monitoring perfusion pressure,temperature, chemical compositions and for withdrawing fluid samples orfor injecting medications or other fluids. Likewise, the arch perfusionlumen 910 is connected to a Y-fitting 964 that has a barb connector 956for connection to a perfusion pump and a luer connector 958 which may beused for monitoring arch perfusion pressure, temperature, chemicalcompositions and for withdrawing fluid samples or for injectingmedications or other fluids. The common balloon inflation lumen 912 isconnected to a stopcock or luer connector 960 or other fitting suitablefor connection to a syringe or balloon inflation device. In addition theinflation lumen 912 may be attached to a pressure monitoring device togive visible and or tactile feedback concerning the balloon inflationpressure. The guide wire and cardioplegia lumen 916 is connected to athree-way Y-fitting 970 that has a barb connector 972 for connection toa cardioplegia infusion pump, a luer connector 974 capable of monitoringroot perfusion pressure, temperature and chemical compositions and aguide wire port 976 with a Touhy-Borst adapter or other hemostasisvalve. The root pressure lumen 918 is connected to a luer connector 968or other suitable fitting capable of monitoring arch perfusion pressure,temperature and chemical compositions or for withdrawing fluid samples.The arch monitoring lumen 914 is connected to a luer connector 966 orother suitable fitting capable of monitoring arch perfusion pressure,temperature, and chemical compositions or for withdrawing fluid samples.Alternatively, sensors may be placed on the catheter shaft or inside thecatheter shaft to measure chemical compositions in the aortic arch.

[0084]FIG. 11 illustrates a side view of a dual lumen venous drainagecannula 1199 of the present invention configured for introductionthrough the patient's inferior vena cava via the femoral vein or othersuitable venous access point in the lower extremities. Alternatively,the dual lumen venous drainage cannula 1199 may be configured forintroduction though the patient's superior vena cava via the jugularvein or other suitable venous access point in the neck or upperextremities. The elongated tubular shaft 1198 may be fabricatedseparately by known extrusion methods and joined together end-to-end,for example by heat welding or by adhesive bonding. Alternatively, theelongated tubular shaft 1198 may be fabricated by dipping or bycomposite construction techniques and joined together or the entiretubular shaft 1198 may be fabricated integrally. Suitable materials forthe elongated tubular shaft 1198 include, but are not limited to,polyvinylchloride, polyurethane, polyethylene, polypropylene, polyamides(nylons), polyesters, silicone, latex, and alloys or copolymers thereof,as well as braided, coiled or counterwound wire or filament reinforcedcomposites.

[0085]FIG. 12 is a magnified lateral cross section of the venousdrainage cannula 1199 taken along line 12-12 of FIG. 11. FIG. 13 is amagnified lateral cross section of the venous drainage cannula 1199taken along line 13-13 of FIG. 11. Collectively FIGS. 11 through 13illustrate the multi-lumen arrangement of the dual-lumen venous drainagecannula 1199 having an elongated tubular shaft 1198 which includes afirst venous drainage lumen 1188; a second venous drainage lumen 1189; afirst balloon inflation lumen 1191, and a second balloon inflation lumen1194. Alternatively, the dual-lumen venous drainage cannula 1199 mayhave a common balloon inflation lumen capable of simultaneouslyinflating both occlusion balloons. The tubular shaft 1198 preferably hasa length of approximately 15 cm to 90 cm and a diameter of approximately10 to 32 French (3.3 mm to 10.7 mm diameter).

[0086] The dual-lumen venous drainage cannula 1199 includes a firstocclusion balloon 1197 or other expandable occlusion member mounted onthe tubular shaft 1198, which is positioned within the patient'ssuperior vena cava when in the operative position, and a secondocclusion balloon 1196 or other expandable occlusion member, mounted onthe tubular shaft 1198, which is positioned within the patient'sinferior vena cava when in the operative position. Suitable materialsfor the first occlusion member 1197 and the second occlusion member 1196include flexible polymers and elastomers, which include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, latex, silicone, andalloys, copolymers and reinforced composites thereof. The occlusionballoons 1196 and 1197 preferably have an expanded diameter ofapproximately 5 mm to 40 mm. When the dual-lumen venous drainage cannula1199 is configured for femoral artery introduction, the first occlusionballoon 1197 is mounted near the distal end 1195 of the tubular shaft1198 and the second occlusion balloon 1196 is mounted somewhat proximalto the first balloon 1197, as shown. Alternatively, for jugular veinintroduction, these positions are reversed.

[0087] A first balloon inflation lumen 1191 is connected to a stopcock1190 that extends through the tubular shaft 1198 to a balloon inflationport 1192 within the first occlusion balloon 1197. The second ballooninflation lumen 1194, is connected to a stopcock 1193, that extendsthrough the tubular shaft 1198 to a balloon inflation port 1123 withinthe second occlusion balloon 1196. Alternatively, a common ballooninflation lumen may be implemented and a superior vena cava monitoringlumen may be implemented to monitor pressure, temperature and chemicalcomposition in the superior vena cava.

[0088] The first venous drainage lumen 1188 extends from a venousdrainage fitting 1187 through the tubular shaft 1198, to one or moresuperior vena cava drainage ports 1195 on the tubular shaft 1198 distalto the first occlusion balloon 1197. In addition, venous drainage ports1182 which are distal to the second occlusion balloon 1196 are also influid communication with the first venous drainage lumen 1188.Alternatively, the venous drainage ports 1182 may be in fluidcommunication with the second venous drainage lumen 1189. The secondvenous drainage lumen 1189 extends from a venous drainage fitting 1181through the tubular shaft 1198, to one or more inferior vena cavadrainage ports 1173 on the tubular shaft 1198 proximal to the secondocclusion balloon 1196. Preferably, the distal portion of the tubularshaft 1198 is smoothly tapered or rounded for easy introduction and toavoid trauma or injury to the vena cava during insertion or withdrawalof the venous cannula 1199.

[0089] Preferably, the venous cannula includes one or more markers,which may include radiopaque markers and/or sonoreflective markers, toenhance imaging of the venous cannula 1199 using fluoroscopy orultrasound, such as transesophageal echocardiography (TEE). In thisillustrative embodiment, the venous drainage cannula 1199 includes adistal radiopaque marker 1178 positioned near the distal end 1195 of thetubular shaft 1198, an intermediate radiopaque marker 1177 positionednear the drainage ports 1182, and a proximal radiopaque marker 1176positioned near the distal edge of the second occlusion member 1196.Each of the radiopaque markers 1178, 1177, 1176 may be made of a ring ofdense radiopaque metal, such as gold, platinum, tantalum, tungsten oralloys thereof, or a ring of a polymer or adhesive material heavilyloaded with a radiopaque filler material.

[0090] The proximal end 1183 of the venous drainage cannula 1199 isconnected to a manifold 1125 with fittings for each of the catheterlumens. The first venous drainage lumen 1188 is coupled to a three-wayfitting 1187 that has a barb connector 1186 for connection to anexternal CPB machine, a luer connector 1185 capable of monitoringsuperior vena cava pressure, temperature and chemical compositions and aguide wire port 1184 with a Touhy-Borst adapter or other hemostasisvalve on the proximal end of the cannula 1183. The second venousdrainage lumen 1189 is coupled to a Y-fitting 1181 having a barbconnector 1180, or other suitable fitting capable of being coupled to aCPB machine and a luer fitting 1179 capable of monitoring inferior venacava pressure, temperature and chemical compositions. A first inflationlumen 1191 is coupled to a stopcock 1190, or other suitable fittingcapable of being attached to an inflation mechanism and a secondinflation lumen 1194 is coupled to a stopcock 1193, or other suitablefitting capable of being attached to an inflation mechanism. Inaddition, each inflation lumen may have an individualpressure-monitoring device proximal or distal to the stopcock to providevisible and tactile feedback concerning the balloon inflation pressures.Alternatively, a common inflation lumen may be implemented.

[0091]FIG. 14 illustrates the second embodiment of the closed loopcirculatory system of the present invention. FIG. 15 is a cutawayclose-up view of the cannula placement as shown in FIG. 14 with aportion of the patient's heart cut away to better show the descendingaorta. The cerebral loop of the circulatory support system is created byhaving venous drainage ports 1495 and 1482 in fluid communication withthe superior vena cava drainage lumen 1488. Coupled to the superior venacava drainage lumen 1488 is a fitting 1487 having a barb connector 1486coupled to tubing 1449 in fluid communication with an inflow port 1448of a first blood circulation pump 1447. The blood is conditioned andpumped through the outflow port 1446 of the first blood circulation pump1447 to the arch perfusion lumen 1410 of the arterial cannula 1400. Thefirst blood circulation pump 1447 may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump.Preferably, the cerebral loop of the circulatory support system willalso include a venous blood reservoir 1401, a blood oxygenator 1403 andheat exchanger 1402 in series with the first blood circulation pump1447. Optionally, vacuum assist may be used to enhance venous drainagethrough the first venous drainage lumen 1488 of the dual-lumen venousdrainage cannula 1499. Venous blood from the head and upper extremitiesenters the patient's superior vena cava and is drained out through thefirst venous drainage lumen 1488 of the dual-lumen venous drainagecannula 1499 as the first occlusion balloon 1497 prevents blood fromtraveling into the right atrium from the superior vena cava. The bloodis oxygenated, cooled and recirculated by the first blood circulationpump 1447 to the head and upper extremities through the arch perfusionlumen 1410 of the arterial cannula 1400.

[0092] The corporeal loop of the circulatory support system is createdby having a venous drainage port 1478 in fluid communication withinferior vena cava drainage lumen 1489. A second Coupled to the secondvenous drainage lumen 1489 is a fitting 1481 having a barb connector1480 coupled to tubing 1477 in fluid communication with an inflow port1451 of a second blood circulation pump 1455. After the blood isconditioned it is pumped through outflow port 1457 in fluidcommunication with tubing 1459 which is coupled to a barb connector 1452in fluid communication the corporeal lumen 1408 of the aortic catheter1400. The second blood circulation pump may be a peristaltic rollerpump, a centrifugal blood pump or other suitable blood circulation pump.Preferably, the corporeal loop of the circulatory support system willalso include a venous blood reservoir 1404, a blood oxygenator 1406 andheat exchanger 1405 in series with the second blood circulation pump1455. Optionally, vacuum assist may be used to enhance venous drainagethrough the second venous drainage lumen of the dual-lumen venousdrainage cannula 1400. Venous blood from the viscera and lowerextremities enters the patient's inferior vena cava and is drained outthrough the second venous drainage lumen 1489 of the dual-lumen venousdrainage cannula 1499. The blood is oxygenated, cooled and recirculatedby the second blood circulation pump 1455 to the viscera and lowerextremities through the corporeal perfusion lumen 1408 of the arterialcatheter 1400.

[0093] Optionally, the dual-lumen venous drainage cannula 1499 may bemade without either the first occlusion balloon or the second occlusionballoon or one of the balloons may be partially deflated or completelydeflated when operating in this mode since isolation of the patient'sright atrium and the coronary sinus is unnecessary. Alternatively, thedual-lumen venous drainage cannula 1499 may be provided with a thirdvenous drainage lumen within the tubular shaft connected to the drainageports 1482 between the first and second balloons for draining thepatient's right atrium and the coronary sinus. A separate coronaryperfusion loop can be created by connecting the third venous drainagelumen to the inflow of a third blood circulation pump and connecting theoutflow of the pump to the cardioplegia lumen of the arterial cannula1400. The third blood circulation pump may be a peristaltic roller pump,a centrifugal blood pump or other suitable blood circulation pump.Preferably, the coronary loop also includes a venous blood reservoir, ablood oxygenator and heat exchanger in series with the third bloodcirculation pump.

[0094] As another alternative, the coronary circulation can be isolatedby inserting a coronary sinus catheter via the jugular vein to isolatethe coronary circulation on the venous side and for antegrade orretrograde flow of blood, cardioplegia or other fluids into thepatient's coronary arteries. The first occlusion balloon 1495 could beeliminated from the dual-lumen venous drainage cannula 1499 or leftuninflated so that the patient's right atrium will be drained as part ofthe cerebral loop.

[0095]FIGS. 16 through 23 collectively illustrate a third embodiment ofthe circulatory support system of the present invention, which is alsoconfigured for selective, isolated, dual-loop perfusion of a patient'scirculatory system. The circulatory support system has a cerebral loopfor perfusion of the patient's cerebral circulation and upperextremities and a separate corporeal loop for perfusion of the patient'sviscera and lower extremities. As in the previously describedembodiment, the patient's coronary circulation may optionally beincluded in the cerebral loop or the corporeal loop or a third, isolatedcoronary loop may be created through the use of a separate coronarysinus catheter or through a separate pump. In this third embodiment ofthe circulatory support system, arterial cannulation is provided by acoaxial dual-balloon, selective arterial perfusion cannula 1600 andvenous cannulation is provided by a coaxial dual-lumen venous drainagecannula 1799.

[0096]FIG. 16 illustrates a side view of the aortic catheter 1600according to the present invention with a coaxial catheter shaft 1602configured for retrograde deployment via femoral artery access.Alternatively, a separate contralateral or colateral arterial cannulamay be provided to provide perfusion to the corporeal body throughseparate cannulation of the a second peripheral artery. In order tofacilitate placement of the aortic catheter 1600 and to improve thestability of the catheter 1600 in the proper position in the patient'saorta, a distal region 1644 of the catheter shaft 1602 may be preshapedwith a curve to match the internal curvature of the patient's aorticarch. The curved distal region 1644 represents a J-shaped curve ofapproximately 180 degrees of arc with a radius of curvature ofapproximately 2 to 4 cm to match the typical curvature of the aorticarch in an adult human patient. In addition, the distal end 1606 of thecatheter may be skewed slightly up out of the plane of the curve toaccommodate the forward angulation of the patient's ascending aorta.Additionally, the catheter shaft 1602 may be reinforced, particularly inthe curved distal region 1644, for example with braided or coiled wire,to further improve the stability of the catheter 900 in the properposition in the patient's aorta.

[0097] Illustrated in FIG. 17, is a magnified lateral cross section ofthe aortic catheter 1600 of FIG. 16 taken along line 17-17 showing themulti-lumen coaxial arrangement of the catheter shaft 1602. The cathetershaft 1602 has six lumens: a corporeal perfusion lumen 1608; an archperfusion lumen 1610; a common balloon inflation lumen 1612; an archmonitoring lumen 1614; a guide wire and cardioplegia lumen 1616 and aroot pressure lumen 1618.

[0098]FIG. 18 is a magnified lateral cross-section of the aorticcatheter 1600 of FIG. 16 taken along line 18-18 showing the multi-lumenarrangement of the catheter shaft 1602. Shown in FIG. 18, five of thesix lumens continue distally through the catheter shaft 1602: the archperfusion lumen 1610; the common balloon inflation lumen 1612; the archmonitoring lumen 1614; the guide wire and cardioplegia lumen 1616 andthe root pressure lumen 1618. The corporeal perfusion lumen terminatesat a position distal to the corporeal perfusion ports 1624.

[0099] Referring to FIGS. 16 through 18 the elongated catheter iscomprised of an inner tubular shaft and an outer tubular shaftconfigured in a coaxial relationship such that an annular space iscreated therebetween. The annular space between the tubular shafts 1603and 1606 defines the corporeal lumen 1608. The tubular shafts 1603 and1606 are preferably formed of a flexible thermoplastic material, athermoplastic elastomer or a thermoset elastomer. The coaxial cathetershaft 1602 may be fabricated separately by known extrusion methods andjoined together end-to-end, for example by heat welding or by adhesivebonding. Alternatively, the coaxial catheter shaft 1602 may befabricated by dipping or by composite construction techniques and joinedtogether or the entire catheter shaft 1602 may be fabricated integrally.Suitable materials for the elongated catheter shaft 1602 include, butare not limited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, silicone, latex, andalloys or copolymers thereof, as well as braided, coiled or counterwoundwire or filament reinforced composites.

[0100] An upstream occlusion member 1620 is mounted on the inner tubularshaft 1603 near the distal end 1606 of the catheter 1600. The upstreamocclusion member 1620 in this embodiment is in the form of anexpandable, inflatable balloon bonded to the catheter shaft 1602 by heatwelding or with an adhesive. Suitable materials for the upstreamocclusion member 1620 include flexible polymers and elastomers, whichinclude, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Inaddition, the outer surface of the upstream occlusion member 1620 mayinclude a friction increasing coating or texture to increase frictionwith the aortic wall when deployed. The upstream occlusion member 1620has a deflated state, in which the diameter of the occlusion member 1620is preferably not much larger than the diameter of the catheter shaft1602, and an inflated state, in which the occlusion member 1620 expandsto a diameter sufficient to occlude blood flow in the ascending aorta ofthe patient. For use in adult human patients, the inflatable balloonupstream occlusion member 1620 preferably has an inflated outer diameterof approximately 1.5 cm to 5.0 cm. Preferably, the inflatable occlusionmember 1620 has an inflated length that is not significantly longer thanits inflated diameter, or, more preferably, is shorter than its inflateddiameter. This shortened inflated profile allows the upstream occlusionmember 1620 to be easily placed within the ascending aorta between thecoronary arteries and the brachiocephalic artery without any danger ofinadvertently occluding either.

[0101] A downstream occlusion member 1622 is mounted on the cathetershaft 1602 at a position proximal to and spaced apart from the upstreamocclusion member 1620. The distance between the upstream occlusionmember 1620 and the downstream occlusion member 1622 is preferablybetween 3 and 20 cm, more preferably between 8 and 15 cm, and is chosenso that when the aortic catheter 1600 is deployed and the upstreamocclusion member 1620 is positioned within the ascending aorta betweenthe coronary arteries and the brachiocephalic artery, the downstreamanchoring member 1622 will be positioned in the descending aortadownstream of the left subclavian artery. The downstream occlusionmember 1622 in this embodiment is in the form of an expandable,inflatable balloon bonded to the catheter shaft 1602 by heat welding orwith an adhesive. Suitable materials for the inflatable balloondownstream anchoring member 1622 include flexible polymers andelastomers, which include, but are not limited to, polyvinylchloride,polyurethane, polyethylene, polypropylene, polyamides (nylons),polyesters, latex, silicone, and alloys, copolymers and reinforcedcomposites thereof. In addition, the outer surface of the downstreamanchoring member 1622 may include a friction increasing coating ortexture to increase friction with the aortic wall when deployed.

[0102] The inflatable downstream occlusion member 1622 has a deflatedstate, in which the diameter of the occlusion member 1622 is preferablynot much larger than the diameter of the catheter shaft 1602, and aninflated state, in which the occlusion member 1622 expands to a diametercapable of regulating blood flow in the descending aorta of the patient.Therefore, to gain desired results the downstream occlusion member maybe completely inflated, or partially inflated. For use in adult humanpatients, the downstream occlusion member 1622 preferably has aninflated outer diameter of approximately 1.0 cm to 5.0 cm and a lengthof approximately 1.0 cm to 7.5 cm.

[0103] The corporeal perfusion lumen 1608 extends through the cathetershaft 1602 from the proximal end 1604 to one or more corporeal perfusionports 1624 on the exterior of the catheter shaft 1602 proximal of thedownstream occlusion member 1622. The arch perfusion lumen 1610 extendsthrough the catheter shaft 1602 from the proximal end 1604 to one ormore arch perfusion ports 1626 on the exterior of the catheter shaft1602 between the upstream occlusion member 1620 and the downstreamocclusion member 1622. A common balloon inflation lumen 1612 extendsthrough the catheter shaft 1602 from the proximal end 1604 to ballooninflation ports 1632 and 1630 which reside in the interior of downstreamocclusion balloon 1622 and the upstream occlusion balloon 1620respectively. Alternatively, separate inflation lumens can beimplemented to separately inflate the downstream occlusion member 1622and the upstream occlusion member 1620.

[0104] The arch monitoring lumen 1614 extends through the catheter shaft1602 from the proximal end 1604 to an arch monitoring port 1634 proximalto the upstream occlusion member 1620 to monitor pressure in the aorticarch though the lumen 1614 or by providing a separate sensor slidablydisposed in the lumen 1614. The root pressure lumen 1618 extends throughthe catheter shaft 1602 from the proximal end 1604 to a root pressureport 1628 near the distal end 1606 of the catheter shaft 1602 to monitorpressure in the aortic root through the lumen 1618 or through a separatesensor slidably disposed in the lumen 1618. The guide wire andcardioplegia lumen 1616 extends from the proximal end 904 of thecatheter shaft 1602 to a guide wire/cardioplegia port 1636 at the distalend 1606 of the catheter shaft 1602, distal to the upstream occlusionmember 1620. Preferably, the distal end 1606 of the catheter shaft 1602is smoothly tapered or rounded for easy introduction and to avoid traumaor injury to the aortic wall during insertion or withdrawal of theaortic catheter 1600.

[0105] Preferably, the aortic catheter 1600 includes one or moremarkers, which may include radiopaque markers and/or sonoreflectivemarkers, to enhance imaging of the aortic catheter 900 using fluoroscopyor ultrasound, such as transesophageal echocardiography (TEE). In thisillustrative embodiment, the aortic catheter 1600 includes a distalradiopaque marker 1638 positioned near the distal end 1606 of thecatheter shaft 1602, an intermediate radiopaque marker 1640 positionednear the proximal edge of the upstream occlusion member 1620, and aproximal radiopaque marker 1642 positioned near the distal edge of thedownstream anchoring member 1622. Each of the radiopaque markers 1638,1640, 1642 may be made of a ring of dense radiopaque metal, such asgold, platinum, tantalum, tungsten or alloys thereof, or a ring of apolymer or adhesive material heavily loaded with a radiopaque fillermaterial.

[0106] The proximal end 1604 of the catheter shaft 1602 is connected toa manifold 1650 with fittings for each of the catheter lumens. Thecorporeal perfusion lumen 1608 is connected to a Y-fitting 1662 that hasa barb connector 1652 for connection to a perfusion pump or the like anda luer connector 1654, which may be used for monitoring perfusionpressure, temperature, chemical compositions and for withdrawing fluidsamples or for injecting medications or other fluids. Likewise, thearchperfusion lumen 1610 is connected to a Y-fitting 1664 that has abarb connector 1656 for connection to a perfusion pump and a luerconnector 1658 which may be used for monitoring arch perfusion pressure,temperature, chemical compositions and for withdrawing fluid samples orfor injecting medications or other fluids. The common balloon inflationlumen 1612 is connected to a stopcock or luer connector 1660 or otherfitting suitable for connection to a syringe or balloon inflationdevice. In addition the inflation lumen may have a pressure monitoringballoon proximal or distal to the stopcock or luer fitting to givevisible and tactile feedback concerning the balloon inflation pressure.The guide wire and cardioplegia lumen 1616 is connected to a three-wayY-fitting 1670 that has a barb connector 1672 for connection to acardioplegia infusion pump, a luer connector 1674 capable of monitoringroot perfusion pressure, temperature and chemical compositions and aguide wire port 1676 with a Touhy-Borst adapter or other hemostasisvalve. The root pressure lumen 1618 is connected to a luer connector1668 or other fitting suitable capable of monitoring arch perfusionpressure, temperature and chemical compositions or for withdrawing fluidsamples. The arch monitoring lumen 1614 is connected to a luer connector1666 or other fitting suitable capable of monitoring arch perfusionpressure, temperature, chemical compositions or for withdrawing fluidsamples.

[0107]FIG. 19 illustrates a side view of a coaxial dual lumen venousdrainage cannula 1999 of the present invention configured forintroduction through the patient's inferior vena cava via the femoralvein or other suitable venous access point in the lower extremities.Alternatively, the coaxial dual lumen venous drainage cannula 1999 maybe configured for introduction though the patient's superior vena cavavia the jugular vein or other suitable venous access point in the neckor upper extremities. The elongated coaxial tubular shaft 1998 may befabricated separately by known extrusion methods and joined togetherend-to-end, for example by heat welding or by adhesive bonding.Alternatively, the elongated coaxial tubular shaft 1998 may befabricated by dipping or by composite construction techniques and joinedtogether or the entire elongated coaxial tubular shaft 1998 may befabricated integrally. Suitable materials for the elongated coaxialtubular shaft 1998 include, but are not limited to, polyvinylchloride,polyurethane, polyethylene, polypropylene, polyamides (nylons),polyesters, silicone, latex, and alloys or copolymers thereof, as wellas braided, coiled or counterwound wire or filament reinforcedcomposites.

[0108]FIG. 20 is a magnified lateral cross section of the coaxial duallumen venous drainage cannula 1999 taken along line 20-20 of FIG. 19.FIG. 21 is a magnified lateral cross section of the coaxial dual lumenvenous drainage cannula 1999 taken along line 21-21 of FIG. 19.Collectively FIGS. 19 through 21 illustrate the multi-lumen arrangementwherein the inner tubular shaft 1915 and an outer tubular shaft 1917 areconfigured in a coaxial relationship such that an annular space iscreated therebetween, which defines the corporeal venous drainage lumen1989. The venous coaxial multi-lumen drainage cannula 1900 is furthercomprised of a cerebral drainage lumen 1988, which is defined by theinternal diameter of the inner tubular shaft 1915, a first ballooninflation lumen 1991, and a second balloon inflation lumen 1994. Thetubular shaft 1998 preferably has a length of approximately 15 cm to 90cm and a diameter of approximately 10 to 32 French (3.3 mm to 10.7 mmdiameter).

[0109] The dual-lumen venous drainage cannula 1999 includes a firstocclusion balloon 1997 or other expandable occlusion member, mounted onthe tubular shaft 1998, which is positioned within the patient'ssuperior vena cava when in the operative position, and a secondocclusion balloon 1996 or other expandable occlusion member, mounted onthe tubular shaft 1998, which is positioned within the patient'sinferior vena cava when in the operative position to create asegmentation of venous blood flow in the superior and inferior venacava. Suitable materials for the first occlusion member 1997 and thesecond occlusion member 1996 include flexible polymers and elastomers,which include, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, latex,silicone, and alloys, copolymers and reinforced composites thereof. Theocclusion balloons 1996 and 1997 preferably have an expanded diameter ofapproximately 5 mm to 40 mm. When the coaxial dual-lumen venous drainagecannula 1999 is configured for femoral artery introduction, the firstocclusion balloon 1997 is mounted near the distal end 1995 of the innertubular shaft 1915 and the second occlusion balloon 1996 is mountedsomewhat proximal to the first balloon 1997, on the outer tubular shaft1917. Alternatively, for jugular vein introduction, the positions of theocclusion balloons are reversed.

[0110] A first balloon inflation lumen 1991 is connected to a stopcock1990 that extends through the tubular shaft 1998 to a balloon inflationport 1992 within the first occlusion balloon 1997. The second ballooninflation lumen 1994, is connected to a stopcock 1993, that extendsthrough the tubular shaft 1998 to a balloon inflation port 1923 withinthe second occlusion balloon 1996.

[0111] The cerebral venous drainage lumen 1988 extends from a proximalvenous drainage fitting 1987 in fluid communication with an external CPBmachine through the tubular shaft 1998, to one or more superior venacava drainage ports 1995 on the tubular shaft 1998 distal to the firstocclusion balloon 1997. In addition, venous drainage ports 1982 whichare proximal to the first occlusion balloon 1997 are also in fluidcommunication with the first venous drainage lumen 1988. Alternatively,the venous drainage ports 1982 may be in fluid communication with thecorporeal venous drainage lumen 1989. Alternatively, a separate lumenmay be provided to completely isolate the myocardial circulation. Thecorporeal venous drainage lumen 1989 extends from a proximal venousdrainage fitting 1981 in fluid communication with an external CPBmachine through the tubular shaft 1998, to one or more inferior venacava drainage ports 1978 on the tubular shaft 1998 proximal to thesecond occlusion balloon 1996. Preferably, the distal portion of thetubular shaft 1998 is smoothly tapered or rounded for easy introductionand to avoid trauma or injury to vena cava during insertion orwithdrawal of the coaxial multi-lumen venous cannula 1999.

[0112] Preferably, the coaxial multi-lumen venous cannula 1999 includesone or more markers, which may include radiopaque markers and/orsonoreflective markers, to enhance imaging of the venous cannula 1999using fluoroscopy or ultrasound, such as transesophagealechocardiography (TEE). In this illustrative embodiment, the multilumencoaxial venous drainage cannula 1999 includes a distal radiopaque marker1908 positioned near the distal end of the tubular shaft 1998, anintermediate radiopaque marker 1977 positioned near the drainage ports1982, and a proximal radiopaque marker 1976 positioned near the distaledge of the second occlusion member 1996. Each of the radiopaque markers1908, 1977, 1976 may be made of a ring of dense radiopaque metal, suchas gold, platinum, tantalum, tungsten or alloys thereof, or a ring of apolymer or adhesive material heavily loaded with a radiopaque fillermaterial.

[0113] The proximal end 1983 of the coaxial multi-lumen venous drainagecannula 1999 is capable of receiving the inner tubular member andcreating a fluid tight seal through the Touhy-Borst adapter 1931 orother suitable hemostasis valve capable of receiving a second catheterinstrument. The cerebral venous drainage lumen 1988 is coupled to aY-fitting 1987 that has a barb connector 1986 for connection to anexternal CPB machine, a luer connector 1985 capable of monitoringsuperior vena cava pressure, temperature and chemical compositions. Thecorporeal venous drainage lumen 1989 is coupled to a three-way fitting1981 having a barb connector 1980, or other suitable fitting capable ofbeing coupled to a CPB machine, a luer fitting 1979 capable ofmonitoring inferior vena cava pressure, temperature and chemicalcompositions and a guide wire port 1984 with a Touhy-Borst adapter 1931or other hemostasis valve. A first inflation lumen 1991 is coupled to astopcock 1990, or other suitable fitting capable of being attached to aninflation mechanism and a second inflation lumen 1994 is coupled to astopcock 1993, or other suitable fitting capable of being attached to aninflation mechanism. In addition, each inflation lumen may have anindividual pressure-monitoring device proximal or distal to the stopcockto provide visible and tactile feedback concerning the balloon inflationpressures.

[0114]FIG. 22 illustrates a third embodiment of the support system ofthe present invention configured for selective, isolated, dual-loopperfusion of a patient's circulatory system. The circulatory supportsystem has a cerebral loop for perfusion of the patient's cerebralcirculation and upper extremities and a separate corporeal loop forperfusion of the patient's viscera and lower extremities. As in thepreviously described embodiments, the patient's coronary circulation mayoptionally be included in the cerebral loop or the corporeal loop or athird, isolated coronary loop may be created. In this embodiment of thecirculatory support system, arterial cannulation is provided by adual-balloon, coaxial selective arterial perfusion cannula 2200 andvenous cannulation is provided by a dual-lumen, coaxial venous drainagecannula 2299. A cutaway close-up view of the cannula placement is shownin FIG. 23 with a portion of the patient's heart cut away to better showthe descending aorta.

[0115] The dual-lumen, coaxial venous drainage cannula 2299 may beconfigured for introduction though the patient's inferior vena cava viathe femoral vein or other suitable venous access point in the lowerextremities, as shown, or, alternatively, it may configured forintroduction through the patient's superior vena cava via the jugularvein or other suitable venous access point in the neck or upperextremities. The dual-lumen coaxial venous drainage cannula 2299 has aninner tubular shaft 2215 that includes a first venous drainage lumen2288 for draining venous blood from the patient's superior vena cava andan outer, coaxial tubular shaft 2217 that includes a second, coaxialvenous drainage lumen 2289 for draining venous blood from the patient'sinferior vena cava. In addition, the inner tubular shaft 2215 includes afirst balloon inflation lumen 2291 and the outer tubular shaft 2217includes a second balloon inflation lumen 2294 for inflating theballoons to enable the segmentation of the vena cava to isolate thecerebra, corporeal and myocardial circulation. The inner and outertubular shafts 2215 and 2217 preferably have a length of approximately15 cm to 90 cm and the outer tubular shaft 2217 preferably has adiameter of approximately 10 to 32 French (3.3 mm to 10.7 mm diameter).A first occlusion balloon 2297 or other expandable occlusion membermounted near the distal end of the inner tubular shaft 2215 and a secondocclusion balloon 2296 or other expandable occlusion member is mountednear the distal end of the outer tubular shaft 2217. The occlusionballoons 2297 and 2296 or other expandable occlusion members preferablyhave an expanded diameter of approximately 5 mm to 40 mm. The innertubular shaft 2215 is slidable within a hemostasis seal 2231 at theproximal end of the outer tubular shaft 2217. This allows adjustment ofthe distance between the first occlusion balloon 2297 and secondocclusion balloon 2296 so that the first occlusion balloon 2297 can bepositioned within the patient's superior vena cava, and the secondocclusion balloon 2296 can be positioned within the patient's inferiorvena cava. Preferably, the hemostasis seal includes a Touhy-Borstfitting or other compression seal that allows the user to selectivelylock the relative position of the inner 2215 and outer 2217 tubularshafts. Optionally, a sliding hemostasis seal may be used at the distalend of the outer tubular shaft to seal the annular space between theinner and outer tubular shafts.

[0116] The superior vena cava drainage lumen 2288 extends through theinner tubular shaft 2215 from a first venous drainage fitting 2287 onthe proximal end of the inner tubular shaft 2215 to one or more superiorvena cava drainage ports 2295 on the inner tubular shaft 2215 distal tothe first occlusion balloon 2297. The superior vena cava drainage lumen2288 may also connect to a distal guidewire port on the end of the innertubular shaft 2215 distal to the first occlusion balloon 2297. Thesecond venous drainage lumen 2289 extends through the tubular shaft 2298within the annular space from a second venous drainage fitting 2281 onthe proximal end of the outer tubular shaft 2217 to one or more inferiorvena cava drainage ports 2278 on the outer tubular shaft proximal to thesecond occlusion balloon 2296. In addition, extra drainage can also beaccomplished through an annular opening 2273, and extra venous drainageports 2282 distal to the second occlusion balloon 2296.

[0117] The cerebral loop of the circulatory support system is created byconnecting the superior vena cava venous drainage lumen 2288 of theinner tubular shaft 2215 to the inflow 2248 of a first blood circulationpump 2247 using suitable blood flow tubing 2249, then connecting theoutflow 2246 of the first blood circulation pump 2247 to the archperfusion lumen 2210 of the arterial cannula 2200. The first bloodcirculation pump 2247 may be a peristaltic roller pump, a centrifugalblood pump or other suitable blood circulation pump. Preferably, thecerebral loop of the circulatory support system will also include avenous blood reservoir 2201, a blood oxygenator 2203 and heat exchanger2202 in series with the first blood circulation pump 2247. Optionally,vacuum assist may be used to enhance venous drainage through the firstvenous drainage lumen 2288 of the inner tubular shaft 2215. Venous bloodfrom the head and upper extremities is partitioned into the superiorvena cava lumen 2288 by the first occlusion balloon 2297 and is drainedout through the superior vena cava venous drainage lumen 2288 of theinner tubular shaft 2215. The blood is oxygenated, cooled andrecirculated by the first blood circulation pump 2247 to the head andupper extremities through the arch perfusion lumen 2210 of the arterialcannula 2200.

[0118] The corporeal loop of the circulatory support system is createdby connecting the inferior vena cava venous drainage lumen 2289 of theouter tubular shaft 2217 to the inflow 2251 of a second bloodcirculation pump 2255 using suitable blood flow tubing 2277, thenconnecting the outflow of the second blood circulation pump 2255 to thecorporeal perfusion lumen 2208 of the arterial cannula 2200. The secondblood circulation pump 2255 may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump.Preferably, the corporeal loop of the circulatory support system willalso include a venous blood reservoir 2204, a blood oxygenator 2206 andheat exchanger 2205 in series with the second blood circulation pump2255. Optionally, vacuum assist may be used to enhance venous drainagethrough the inferior vena cava venous drainage lumen 2289 of the tubularshaft 2298. Venous blood from the viscera and lower extremities entersthe patient's inferior vena cava and is partitioned into the inferiorvena cava venous drainage lumen 2289 by the second occlusion balloon2296 and is drained out through the inferior vena cava venous drainagelumen 2289. The blood is oxygenated, cooled and recirculated by thesecond blood circulation pump 2255 to the viscera and lower extremitiesthrough the corporeal perfusion lumen 2208 of the arterial cannula 2200.

[0119] The dual-lumen, coaxial venous drainage cannula 2299 alsoincludes one or more drainage ports 2282 connected with the first venousdrainage lumen 2288 on the inner tubular shaft 2215 between the firstand second balloons 2297 and 2296 for draining the patient's rightatrium and the coronary sinus as part of the cerebral loop.Alternatively, the patient's right atrium and the coronary sinus may bedrained into the inferior vena cava venous drainage lumen 2289 throughthe annular space 2273 between the inner 2215 and outer 2217 tubularshafts as part of the corporeal loop. Optionally, the dual-lumen,coaxial venous drainage cannula 2299 may be made without either thefirst occlusion balloon 2297 or the second occlusion balloon 2296 or oneof the balloons may be deflated when isolation of the patient's rightatrium and the coronary sinus is not needed. Alternatively, thedual-lumen, coaxial venous drainage cannula 2299 may be provided with athird venous drainage lumen within the inner or outer tubular shaftconnected to drainage ports between the first 2297 and second 2296balloons for draining the patient's right atrium and the coronary sinus.A separate coronary perfusion loop can be created by connecting thethird venous drainage lumen to the inflow of a third blood circulationpump and connecting the outflow of the pump to the cardioplegia lumen2216 of the arterial cannula 2200. The third blood circulation pump maybe a peristaltic roller pump, a centrifugal blood pump or other suitableblood circulation pump. Preferably, the coronary loop also includes avenous blood reservoir, a blood oxygenator and heat exchanger in serieswith the third blood circulation pump.

[0120] FIGS. 24 though 29 collectively illustrate a fourth embodiment ofthe circulatory support system of the present invention configured forselective, isolated, dual-loop perfusion of a patient's circulatorysystem. The circulatory support system has a cerebral loop for perfusionof the patient's cerebral circulation and upper extremities and aseparate corporeal loop for perfusion of the patient's viscera and lowerextremities. Optionally, the patient's coronary circulation may beincluded in the cerebral loop or the corporeal loop or a third, isolatedcoronary loop may be created. In this illustrative embodiment, arterialcannulation is provided by a low profile peripheral arterial cannulationsubsystem that includes an aortic arch perfusion cannula 2400 and aseparate corporeal perfusion cannula 2401. Venous cannulation may beprovided by any of previously described venous cannulae, forillustrative purposes, a superior vena cava cannula 399 as described inFIGS. 3 and 4 is used in conjunction with a separate inferior vena cavacannula 589 which was also fully described in FIGS. 5 and 6, theredescriptions are incorporated by reference herein. The use of a lowprofile peripheral arterial cannulation subsystem with separate superiorand inferior vena cava cannulae allows easier cannulation of patientswith smaller peripheral arteries, such as pediatric patients and smalleradults, particularly women. The low profile peripheral arterialcannulation subsystem also allows percutaneous cannulation, without anarterial cutdown, in adult patients with normal sized peripheralarteries.

[0121]FIG. 24 illustrates an aortic arch perfusion cannula of thepresent invention configured for introduction into the aortic archthrough peripheral arterial access in one of the upper extremities, suchas the left or right subclavian artery, axillary artery or brachialartery. Alternatively, a two catheter arterial system may also beaccomplished by cannulating both femoral arteries in a contralateralapproach, or by cannulating the same femoral artery with the secondarterial cannula in a collateral approach. The aortic arch perfusioncannula 2400 has a tubular shaft 2402 preferably having a length ofapproximately 15 cm to 90 cm and a diameter of approximately 10 to 32French (3.3 mm to 10.7 mm diameter). In order to facilitate placement ofthe aortic arch catheter 2400 and to improve the stability of thecatheter 2400 in the proper position in the patient's aorta, a distalregion 2444 of the catheter shaft 2402 may be preshaped with a curve tomatch the internal curvature of the patient's aortic arch. The curveddistal region 2444 represents an S-shaped curve to match the typicalcurvature of the aortic arch in an adult human patient. In addition, thedistal end 2406 of the catheter may be skewed slightly up out of theplane of the curve to accommodate the forward angulation of thepatient's ascending aorta. Additionally, the catheter shaft 2402 may bereinforced, particularly in the curved distal region 2444, for examplewith braided or coiled wire, to further improve the stability of thecatheter 2400 in the proper position in the patient's aorta.

[0122] Illustrated in FIG. 25, is a magnified lateral cross section ofthe aortic arch perfusion cannula 2400 of FIG. 24 taken along line 25-25of FIG. 24 showing the multi-lumen arrangement of the catheter shaft2402. The cannula shaft 2402 has four lumens including, an archperfusion lumen 2410, a balloon inflation lumen 2412, a cardioplegialumen 2416 and, a root pressure lumen 2418.

[0123] Referring collectively to FIGS. 24 and 25, an occlusion balloon2420 or other expandable occlusion member is mounted near the distal end2406 of the tubular shaft 2402 so that it will be positioned in theascending aorta between the coronary arteries and the rightbrachiocephalic artery, when the balloon 2420 is deployed. The archperfusion lumen 2410 extends through the tubular shaft 2402 from an archperfusion fitting 2464 on the proximal end of the cannula 2400 to one ormore arch perfusion ports 2426 on the tubular shaft 2402 proximal to theocclusion balloon 2420. The cardioplegia lumen 2416 extends through thetubular shaft 2402 from a cardioplegia fitting 2470 on the proximal endof the cannula 2400 to one or more cardioplegia ports 2436 on thetubular shaft 2402 distal to the occlusion balloon 2420. Thecardioplegia lumen 2416 may also serve as a guide wire lumen. In thesealternative embodiments a Touhy-Borst fitting 2476 is in fluidcommunication with the cardioplegia lumen 2416 and is sized anddimensioned for receiving a guide wire to aid in the insertion andplacement of the cannula 2400. A root pressure lumen 2418 extendsthrough the tubular shaft 2402 from a root pressure fitting 2468 on theproximal end of the catheter 2402 to one or more pressure ports 2428 onthe tubular shaft 2402 distal to the occlusion balloon 2420. The ballooninflation lumen 2412 extends through the tubular shaft 2402 from aballoon inflation fitting 2460 on the proximal end of the cannula 2400to a balloon inflation port 2430 within the occlusion balloon 2420. Inaddition, a separate arch monitoring lumen may be incorporated to allowthe monitoring of pressure in the aortic arch proximal to the occlusionballoon 2420. Alternatively, the arch monitoring lumen may be sized andconfigured to slidably receive an arch monitoring sensor to be insertedtherethrough to take measurements in the arch.

[0124] Preferably, the aortic arch catheter 2400 includes one or moremarkers, which may include radiopaque markers and/or sonoreflectivemarkers, to enhance imaging of the aortic arch catheter 2400 usingfluoroscopy or ultrasound, such as transesophageal echocardiography(TEE). In this illustrative embodiment, the aortic arch catheter 2400includes a distal radiopaque marker 2438 positioned near the distal end2406 of the catheter shaft 2402, an intermediate radiopaque marker 2440positioned near the proximal edge of the occlusion member 2420. Each ofthe radiopaque markers 2438 and 2440 may be made of a ring of denseradiopaque metal, such as gold, platinum, tantalum, tungsten or alloysthereof, or a ring of a polymer or adhesive material heavily loaded witha radiopaque filler material.

[0125] The proximal end 2404 of the aortic arch catheter shaft 2402 isconnected to a manifold 2450 with fittings for each of the catheterlumens. The arch perfusion lumen 2410 is connected to a Y-fitting 2464that has a barb connector 2456 for connection to a perfusion pump and aluer connector 2458. The balloon inflation lumen 2412 is connected to astopcock 2460 or other fittings suitable for connection to a syringe orballoon inflation device. The guide wire and cardioplegia lumen 2416 isconnected to a three-way Y-fitting 2470 that has a barb connector 2472for connection to a cardioplegia infusion pump, a luer connector 2474and a guide wire port 2476 with a Touhy-Borst adapter or otherhemostasis valve. The root pressure lumen 2418 is connected to a luerconnector 2468 or other fitting suitable for connection to a pressuremonitor.

[0126]FIG. 26 illustrates a corporeal perfusion cannula of the presentinvention configured for introduction into the descending aorta througha peripheral arterial access in one of the lower extremities, such asthe femoral artery. The corporeal perfusion cannula 2601 has a tubularshaft 2625 preferably having a length of approximately 15 cm to 90 cmand a diameter of approximately 10 to 32 French (3.3 mm to 10.7 mmdiameter). The catheter shaft 2602 may be reinforced, for example withbraided or coiled wire, to further improve the stability of the catheter2600 in the proper position in the patient's aorta.

[0127] Illustrated in FIG. 27 is a magnified lateral cross section ofthe corporeal perfusion cannula 2601 taken along line 27-27 of FIG. 26showing the multi-lumen arrangement of the catheter shaft 2689. Thetubular shaft 2625 has four lumens including; a corporeal perfusionlumen 2608, a balloon inflation lumen 2614, a guide wire lumen 2616 andan arch monitoring lumen 2619.

[0128] Referring collectively to FIGS. 26 and 27, an occlusion balloon2622 or other expandable occlusion member is mounted near the distal endof the tubular shaft 2625. The corporeal perfusion lumen 2608 extendsthrough the tubular shaft 2625 from a corporeal perfusion fitting 2662on the proximal end of the cannula 2604 to one or more corporealperfusion ports 2624 on the tubular shaft 2625 proximal to the occlusionballoon 2622. The guide wire lumen 2616 extends through the tubularshaft 2625 from a guide wire fitting 2633 on the proximal end 2604 ofthe cannula 2600 to a guide wire port 2637 on the tubular shaft 2625distal to the occlusion balloon 2622. The balloon inflation lumen 2614extends through the tubular shaft 2625 from a balloon inflation fitting2666 on the proximal end 2604 of the cannula 2600 to a balloon inflationport 2632 within the occlusion balloon 2622. A corporeal pressuremonitoring lumen 2619 extends through the tubular shaft 2625 from apressure monitoring fitting 2639 on the proximal end 2604 of the cannula2600 to a corporeal pressure port 2607 on the tubular shaft 2625proximal to the occlusion balloon 2622.

[0129] Preferably, the corporeal catheter 2601 includes one or moremarkers, which may include radiopaque markers and/or sonoreflectivemarkers, to enhance imaging of the aortic catheter 100 using fluoroscopyor ultrasound, such as transesophageal echocardiography (TEE). In thisillustrative embodiment, the corporeal catheter 2601 includes a distalradiopaque marker 2638 positioned near the distal end 2606 of thecatheter shaft 2625, an intermediate radiopaque marker 2640 positionednear the proximal edge of the occlusion member 2622, and a proximalradiopaque marker 2640 positioned near the distal edge of the anchoringmember 2622. Each of the radiopaque markers 2638 and 2640 may be made ofa ring of dense radiopaque metal, such as gold, platinum, tantalum,tungsten or alloys thereof, or a ring of a polymer or adhesive materialheavily loaded with a radiopaque filler material.

[0130] The proximal end 2604 of the catheter shaft 2625 is connected toa manifold 2650 with fittings for each of the catheter lumens. Thecorporeal perfusion lumen 2608 is connected to a Y-fitting 2662 that hasa barb connector 2652 for connection to a perfusion pump or the like anda luer connector 2654, which may be used for monitoring perfusionpressure, for withdrawing fluid samples or for injecting medications orother fluids. The balloon inflation lumen 2614 is connected to astopcock connector 2666 or other fitting suitable for connection to asyringe or balloon inflation device. The guide wire lumen 2616 isconnected to a Touhy-Borst adapter 2633 or other hemostasis valve. Thecorporeal pressure lumen 2619 is connected to a luer connector 2639 orother fitting suitable for connection to a pressure monitor.

[0131]FIG. 28 illustrates the circulatory support system of the presentinvention configured for selective, isolated, dual-loop perfusion of apatient's circulatory system. The cerebral loop of the circulatorysupport system is created by connecting the venous drainage lumen 2897of the superior vena cava cannula 2899 to the inflow 2848 of a firstblood circulation pump 2847 using suitable blood flow tubing 2849, thenconnecting the outflow 2846 of the first blood circulation pump 2847 tothe arch perfusion lumen 2810 of the arch perfusion cannula 2800. Thefirst blood circulation pump 2847 may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump.Preferably, the cerebral loop of the circulatory support system willalso include a venous blood reservoir 2822, a blood oxygenator 2802 andheat exchanger 2803 in series with the first blood circulation pump.Optionally, vacuum assist may be used to enhance venous drainage throughthe superior vena cava cannula 2899. Venous blood from the head andupper extremities enters the patient's superior vena cava and is drainedout through the venous drainage lumen 2897 of the superior vena cavacannula 2899. The blood is oxygenated, cooled and recirculated by thefirst blood circulation pump 2847 to the head and upper extremitiesthrough the arch perfusion lumen 2810 of the arch perfusion cannula2800.

[0132] The corporeal loop of the circulatory support system is createdby connecting the venous drainage lumen 2887 of the inferior vena cavacannula 2889 to the inflow 2851 of a second blood circulation pump 2855using suitable blood flow tubing 2877, then connecting the outflow 2857of the second blood circulation pump 2855 to the corporeal perfusionlumen 2808 of the corporeal perfusion cannula 2801. The second bloodcirculation pump 2855 may be a peristaltic roller pump, a centrifugalblood pump or other suitable blood circulation pump. Preferably, thecorporeal loop of the circulatory support system will also include avenous blood reservoir 2804, a blood oxygenator 2806 and heat exchanger2805 in series with the second blood circulation pump. Optionally,vacuum assist may be used to enhance venous drainage through theinferior vena cava cannula 2889. Venous blood from the viscera and lowerextremities enters the patient's inferior vena cava and is drained outthrough the venous drainage lumen 2887 of the inferior vena cava cannula2889. The blood is oxygenated, cooled or warmed and recirculated by thesecond blood circulation pump 2855 to the viscera and lower extremitiesthrough the corporeal perfusion lumen 2808 of the corporeal perfusioncannula 2801.

[0133]FIGS. 29 through 35 collectively illustrate a fifth embodiment ofthe circulatory support system of the present invention configured forselective, isolated, dual-loop perfusion of a patient's circulatorysystem. This embodiment of the circulatory support system is configuredfor central venous and central arterial cannulation using open-chest orminimally-invasive surgical techniques, for example by insertion througha minithoracotomy, partial sternotomy, median sternotomy or thorocotomy.The circulatory support system has a cerebral loop for perfusion of thepatient's cerebral circulation and upper extremities and a separatecorporeal loop for perfusion of the patient's viscera and lowerextremities. Optionally, the patient's coronary circulation may beincluded in the cerebral loop or the corporeal loop or a third, isolatedcoronary loop may be created. In this embodiment of the circulatorysupport system, arterial cannulation is provided by a dual-balloon,selective, central arterial perfusion cannula 2900, and venouscannulation is provided by a central superior vena cava cannula 3199 anda separate central inferior vena cava cannula 3189.

[0134]FIG. 29 illustrates a side view of the dual-balloon, selective,central arterial perfusion cannula 2900 is configured for antegradeintroduction into the patient's aortic arch via a direct puncture orincision in the ascending aorta. Because the aortic catheter 2900 isintroduced directly into the ascending aorta, the elongated cathetershaft 2902 has an overall length of approximately 20 to 60 cm. In orderto facilitate placement of the aortic catheter 2900 and to improve thestability of the catheter 2900 in the proper position in the patient'saorta, a distal region 2944 of the catheter shaft 2902 may be preshapedwith a curve to match the internal curvature of the patient's aorticarch. The curved distal region 2944 represents an S-shaped curve with aprimary curve 2946 of approximately 180 degrees of arc with a radius ofcurvature of approximately 2 to 4 cm to match the typical curvature ofthe aortic arch in an adult human patient and a secondary curve 2948that is a bend of approximately 90 degrees or more where the cathetershaft 2902 will pass through the aortic wall. Additionally, the cathetershaft 2902 may be reinforced, particularly in the curved distal region2944, for example with braided or coiled wire, to further improve thestability of the catheter 2900 in the proper position in the patient'saorta.

[0135] Illustrated in FIG. 30 is a magnified lateral cross section ofthe aortic catheter 2900 of FIG. 29 taken along line 30-30 in FIG. 29illustrating the multi-lumen arrangement of the aortic catheter 2900.The catheter shaft 2902 has six lumens: a guide wire and corporealperfusion lumen 2908, an arch perfusion lumen 2910, an arch monitoringlumen 2912, a balloon inflation lumen 2914, a cardioplegia lumen 2916and a root pressure lumen 2918. The elongated catheter shaft 2902 has anouter diameter which is preferably from approximately 9 to 30 French(3.0-10.0 mm diameter), more preferably from approximately 12 to 18French (4.0-6.0 mm diameter) for adult human patients. Additionally, theaortic catheter 2900 includes a distal radiopaque marker 2938 positionednear the distal end 2906 of the catheter shaft 2902, an intermediateradiopaque marker 2940 positioned near the proximal edge of thedownstream anchoring member 2922, and a proximal radiopaque marker 2942positioned near the distal edge of the upstream occlusion member 2920.

[0136] A downstream occlusion member 2922, in the form of an inflatableballoon, is mounted on the catheter shaft 2902 near the distal end 2906of the catheter shaft 2902. When placed in the operative position, thedownstream occlusion member 2922 may be partially inflated or completelyinflated to a diameter sufficient to regulate blood flow in thedescending aorta. For use in adult human patients, the downstreamocclusion member 2922 preferably has an inflated outer diameter ofapproximately 0.5 cm to 4.0 cm and a length of approximately 1.0 cm to7.5 cm. An upstream occlusion member 2920, in the form of an expandable,inflatable balloon, is mounted on the catheter shaft 2902 at a positionproximal to and spaced apart from the downstream anchoring member 2922so that it is positioned in the ascending aorta when deployed. Thedistance between the upstream occlusion member 2920 and the downstreamocclusion member 2922 is preferably between 3 and 20 cm, more preferablybetween 8 and 15 cm, and is chosen so that, when the aortic catheter2900 is deployed and the upstream occlusion member 2920 is positionedwithin the ascending aorta between the coronary arteries and thebrachiocephalic artery, the downstream occlusion member 2922 will bepositioned in the descending aorta downstream of the left subclavianartery. When inflated, the upstream occlusion member 2920 expands to adiameter sufficient to occlude blood flow in the ascending aorta. Foruse in adult human patients, the inflatable balloon upstream occlusionmember 2920 preferably has an inflated outer diameter of approximately1.5 cm to 4.0 cm. Preferably, the inflatable balloon upstream occlusionmember 2920 has an inflated length that is not significantly longer thanits inflated diameter, or, more preferably, is shorter than its inflateddiameter to allow the upstream occlusion member 2920 to be easily placedwithin the ascending aorta between the coronary arteries and thebrachiocephalic artery without any danger of inadvertently occludingeither.

[0137] The arch perfusion lumen 2910 extends through the catheter shaft2902 from the proximal end 2904 to one or more arch perfusion ports 2926on the exterior of the catheter shaft 2902 between the upstreamocclusion member 2920 and the downstream anchoring member 2922. The archmonitoring lumen 2912 extends through the catheter shaft 2902 from theproximal end to an arch monitoring port 2928 located between theupstream occlusion member 2920 and the downstream anchoring member 2922to monitor pressure in the aortic arch. The root pressure lumen 2918extends through the catheter shaft 2902 from the proximal end 2904 to aroot pressure port 2921 located distal to the downstream anchoringmember 2922 to monitor pressure in the aortic root. The common ballooninflation lumen 2914 extends through the catheter shaft 2902 from theproximal end 2904 to balloon inflation ports 2930, 2932 within theupstream occlusion member 2920 and the downstream anchoring member 2922,respectively. Alternatively, separate inflation lumens may be providedfor independently inflating the upstream occlusion member 2920 and thedownstream anchoring member 2922. The guide wire and corporeal perfusionlumen 2908 extends from the proximal end 2904 of the catheter shaft 2902to one or more corporeal perfusion ports 2924 and a guide wire port 2936at the distal end 2906, distal to the downstream anchoring member 2922.The cardioplegia lumen 2916 extends from the proximal end 2904 of thecatheter shaft 2902 to a cardioplegia port 2966 proximal to the upstreamocclusion member 2920. Alternatively, when a cardioplegia lumen 2926 isnot included a separate cardioplegia needle or catheter may be used toinfuse cardioplegia fluid into the aortic root upstream of the upstreamof the occlusion member 2920.

[0138] The proximal end 2904 of the catheter shaft 2902 is connected toa manifold 2950 with fittings for each of the catheter lumens. The archperfusion lumen 2910 is connected to a Y-fitting 2964 that has a barbconnector 2956 for connection to a perfusion pump or the like and a luerconnector 2958, which may be used for monitoring perfusion pressure, forwithdrawing fluid samples or for injecting medications or other fluids.

[0139] The arch monitoring lumen 2912 is connected to a luer connector2960 or other fitting suitable for connection to a pressure monitor. Theballoon inflation lumen 2914 is connected to a luer connector 2966 orother fitting suitable for connection to a syringe or balloon inflationdevice. The guide wire and corporeal perfusion lumen 2908 is connectedto a three-way Y-fitting 2970 that has a barb connector 2972 forconnection to a perfusion pump, a luer connector 2974 and a guide wireport 2976 with a Touhy-Borst adapter or other hemostasis valve. Thecardioplegia lumen 2916 is connected to a Y-fitting 2971 having a barbconnector 2973 for connection to a cardioplegia source, and a luerconnector 2977.

[0140]FIG. 31 illustrates a side view of the central superior vena cavacannula 3199 of the present invention configured for introduction intothe patient's superior vena cava via an incision in the right atrium.FIG. 32 is a magnified lateral cross-section of the central superiorvena cava cannula 3199 taken along line 32-32 of FIG. 31. The centralsuperior vena cava cannula 3199 has a tubular shaft 3198 that includes avenous drainage lumen 3197 and a balloon inflation lumen 3196. Thetubular shaft preferably has a length of approximately 15 cm to 90 cmand a diameter of approximately 10 to 32 French (3.3 mm to 10.7 mmdiameter). Suitable materials for the elongated tubular shaft 3198include, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, silicone,latex, and alloys or copolymers thereof, as well as braided, coiled orcounterwound wire or filament reinforced composites. In addition, thetubular shaft 3198 may be preformed to better facilitate ease of entryinto the superior vena cava from a right atrium entry site.

[0141] An occlusion balloon 3195 or other expandable occlusion member ismounted on the tubular shaft 3198 near the distal end 3179 of thecannula 3199. The occlusion balloon 3195 or other expandable occlusionmember preferably has an expanded diameter of approximately 5 mm to 40mm. The venous drainage lumen 3197 extends through the tubular shaft3198 from a venous drainage fitting 3194 on the proximal end of thecannula 3199 to one or more venous drainage ports 3193 on the tubularshaft 3198 distal to the occlusion balloon 3195. The venous drainagelumen 3197 may also serve as a guide wire lumen having a proximalTouhy-Borst fitting 3192, or other hemostasis valve capable of creatinga fluid tight seal around a guide wire and guiding catheter, to a guidewire port 3179 on the distal end 3176 of the tubular shaft 3198 distalto the occlusion balloon 3195. In addition, the proximal venous drainagefitting 3194 has a barb connector 3178 or other suitable fitting capableof being coupled to a CPB machine and a luer fitting 3175 capable ofwithdrawing fluid samples in the superior vena cava. The ballooninflation lumen 3196 extends through the tubular shaft 3198 from aballoon inflation fitting 3191 on the proximal end of the catheter 3199to one or more balloon inflation ports 3190 within the occlusionballoon.

[0142]FIG. 33 illustrates a side view of the central inferior vena cavacannula 3389 of the present invention configured for introduction intothe patient's inferior vena cava through the same or another incision inthe right atrium. FIG. 34 is a magnified lateral cross-section of thecentral superior vena cava cannula 3389 taken along line 33-33 of FIG.33. The central inferior vena cava cannula 3389 has a tubular shaft 3188that includes a venous drainage lumen 3387 and a balloon inflation lumen3386. The tubular shaft preferably has a length of approximately 15 cmto 90 cm and a diameter of approximately 10 to 32 French (3.3 mm to 10.7mm diameter). Suitable materials for the elongated tubular shaft 3188include, but are not limited to, polyvinylchloride, polyurethane,polyethylene, polypropylene, polyamides (nylons), polyesters, silicone,latex, and alloys or copolymers thereof, as well as braided, coiled orcounterwound wire or filament reinforced composites. In addition, thetubular shaft 3388 may be preformed to better facilitate ease of entryinto the inferior vena cava from a right atrium entry site.

[0143] An occlusion balloon 3385 or other expandable occlusion member ismounted on the tubular shaft 3388 near the distal end 3366 of thecannula 3389. The occlusion balloon 3385 or other expandable occlusionmember preferably has an expanded diameter of approximately 5 mm to 40mm. The venous drainage lumen 3387 extends through the tubular shaft3388 from a venous drainage fitting 3384 on the proximal end of thecannula 3389 to one or more venous drainage ports 3383 on the tubularshaft 3388 distal to the occlusion balloon 3385. The venous drainagelumen 3387 may also serve as a guide wire lumen having a proximalTouhy-Borst fitting 3382, or other hemostasis valve capable of creatinga fluid tight seal around a guide wire and guiding catheter, to a guidewire port 3369 on the distal end 3366 of the tubular shaft 3388 distalto the occlusion balloon 3385. In addition, the proximal venous drainagefitting 3384 has a barb connector 3365 or other suitable fitting capableof being coupled to a CPB machine and a luer fitting 3367 capable ofwithdrawing fluid samples in the inferior vena cava. The ballooninflation lumen 3386 extends through the tubular shaft 3388 from aballoon inflation fitting 3381 on the proximal end of the catheter 3389to one or more balloon inflation ports 3380 within the occlusionballoon.

[0144]FIG. 35 is a schematic diagram of a fifth embodiment of thecirculatory support system of the present invention configured forselective, isolated, dual loop perfusion of a patient's circulatorysystem. The cerebral loop is created by connecting the venous drainagelumen 3597 of the central superior vena cava cannula 3599 to the inflow3548 of a first blood circulation pump 3547 using suitable blood flowtubing 3549, then connecting the outflow 3546 of the first bloodcirculation pump 3547 to the arch perfusion lumen 3510 of the centralarterial perfusion cannula 3500. The first blood circulation pump 3547may be a peristaltic roller pump, a centrifugal blood pump or othersuitable blood circulation pump. Preferably, the cerebral loop of thecirculatory support system will also include a venous blood reservoir, ablood oxygenator and heat exchanger in series with the first bloodcirculation pump. Optionally, vacuum assist may be used to enhancevenous drainage through the central superior vena cava cannula 3599.Venous blood from the head and upper extremities enters the patient'ssuperior vena cava and is drained out through the venous drainage lumen3597 of the central superior vena cava cannula 3599. The blood isoxygenated, cooled and recirculated by the first blood circulation pump3547 to the head and upper extremities through the arch perfusion lumen3510 of the central arterial perfusion cannula 3599. The corporealcirculation is prevented from mixing with the cerebral circulation onthe venous side by the occlusion balloons 3595 on the superior vena cavacannula 3599 and 3585 on the inferior vena cava cannula 3589. Mixing isprevented in the arterial circulation by upstream occlusion member 3520and downstream occlusion member 3522.

[0145] The corporeal loop of the circulatory support system is createdby connecting the venous drainage lumen 3587 of the central inferiorvena cava cannula 3589 to the inflow 3551 of a second blood circulationpump 3555 using suitable blood flow tubing 3544, then connecting theoutflow 3557 of the second blood circulation pump 3555 to the corporealperfusion lumen 3508 of the central arterial perfusion cannula 3500. Thesecond blood circulation pump 3555 may be a peristaltic roller pump, acentrifugal blood pump or other suitable blood circulation pump.Preferably, the corporeal loop of the circulatory support system willalso include a venous blood reservoir, a blood oxygenator and heatexchanger in series with the second blood circulation pump 3555.Optionally, vacuum assist may be used to enhance venous drainage throughthe central inferior vena cava cannula 540. Venous blood from theviscera and lower extremities enters the patient's inferior vena cavaand is drained out through the venous drainage lumen 3587 of the centralinferior vena cava cannula 3589. The blood is oxygenated, cooled andrecirculated by the second blood circulation pump 3555 to the visceraand lower extremities through the corporeal perfusion lumen 3508 of thecentral arterial perfusion cannula 3500.

[0146] Optionally, the patient's right atrium and the coronary sinus maybe drained through one or more drainage ports 3522 on the centralinferior vena cava cannula 3589 or on the tubular shaft of the centralsuperior vena cava cannula 3599 proximal to the cannula's occlusionballoon 3595. Alternatively, the patient's right atrium and the coronarysinus may be drained into a cardiotomy reservoir using a separatesuction cannula. As another alternative, the coronary circulation can beisolated by inserting a coronary sinus catheter 3525 through the same oranother incision in the right atrium to isolate the coronary circulationon the venous side and for antegrade or retrograde flow of blood,cardioplegia or other fluids into the patient's coronary arteries. Thecoronary sinus catheter 3525 will have a an occlusion balloon to sealthe coronary sinus. Fluid may be perfused in the antegrade direction orfluid may be vacuumed through the coronary sinus catheter in theretrograde direction. The proximal end of the coronary sinus catheter3525 is coupled to tubing 3523 in fluid communication with a separatepump system including a reservoir 3516 a pump 3540 a cardioplegia, ordrug delivery source 3519, a heat exchanger 3533 and an oxygenator 212.The blood, cardioplegia, or drug delivery fluid is conditioned andpumped through tubing 3532 coupled to barb connector 3573 in fluidcommunication with cardioplegia lumen 3516 and distal fluid port 3517.The system creates a retrograde delivery subcirculation or antegradesubcirculation depending upon the rotation of the pump 3540.Alternatively a perfusion pump may be used if total isolation of thecoronary circulation is not necessary which would allow mixing of fluidin the venous system.

[0147] In another aspect of the present invention, the circulatorysupport system can be configured for selective, closed-loop perfusion ofan isolated organ system within the patient's body while the beatingheart supplies the remainder of the circulatory system. In effect, thiscreates an isolated, dual-loop perfusion system with the patient's heartperforming the function of the second blood circulation pump. Aperfusion shunt device is used to allow the patient's heart to continuebeating, while isolating a selected organ system within the body.Suitable perfusion shunt devices for this application are described indetail in commonly owned, copending patent application U.S. Pat. No.09/212,5880, filed Dec. 14, 1998 by Macoviak et al., which is herebyincorporated by reference in its entirety.

[0148]FIGS. 36 through 38 show a sixth embodiment of the circulatorysupport system configured for selective, closed-loop perfusion of anisolated organ system within the patient's body while the beating heartsupplies the remainder of the circulatory system. FIG. 36 is a side viewof the aortic perfusion shunt apparatus 3600 configured for insertioninto a patient's aorta via a peripheral artery such as the femoralartery. FIG. 37 is a distal end view of the expanded shunt device 3602illustrating a shunt conduit 3612 of the aortic perfusion shuntapparatus 3600 of FIG. 36 taken along line 37-37.

[0149] Referring now to FIG. 36, the expandable shunt device 3602 ismounted on an elongated catheter shaft 3620 for introduction into thepatient's circulatory system. In this exemplary embodiment of theperfusion shunt apparatus 3600 the elongated catheter shaft 3620 isconfigured for retrograde deployment of the expandable shunt conduit3602 in a patient's aortic arch via a peripheral arterial access point,such as the femoral artery. Alternatively, it may be adapted forantegrade deployment via direct aortic insertion. The elongated cathetershaft 3620 should have a length sufficient to reach from the arterialaccess point where it is inserted into the patient to the aortic arch.For femoral artery deployment, the elongated catheter shaft 3620preferably has a length from approximately 60 to 120 cm, more preferably70 to 90 cm. The elongated catheter shaft 3620 is preferably extruded ofa flexible thermoplastic material or a thermoplastic elastomer. Suitablematerials for the elongated catheter shaft 3620 include, but are notlimited to, polyvinylchloride, polyurethane, polyethylene,polypropylene, polyamides (nylons), polyesters, and alloys or copolymersthereof, as well as braided, coiled or counterwound wire or filamentreinforced composites. Optionally, the distal end of the catheter shaft3620 may be preshaped with a curve to match the internal curvature ofthe patient's aortic arch.

[0150] Referring now to FIGS. 36 and 37, the elongated catheter shaft3620 has an arch perfusion lumen 3610, a common inflation lumen 3688, anarch monitoring lumen 3611, a guide wire lumen 3615 and a root pressurelumen 3618. The arch perfusion lumen 3610 extends through the cathetershaft 3620 from the proximal end 3604 to one or more arch perfusionports 3626 on the exterior of the catheter shaft 3620 between theupstream sealing member 3608 and the downstream sealing member 3607. Thearch monitoring lumen 3611 extends through the catheter shaft 3620 fromthe proximal end 3604 to an arch monitoring port 3628 located betweenthe upstream sealing mechanism 3608 and the downstream sealing mechanism3607 to monitor pressure in the aortic arch. The root pressure lumen3618 extends through the catheter shaft 3620 from the proximal end 3604to a root pressure port 3601 located distal to the downstream sealingmechanism 3608 to monitor pressure in the aortic root. The commonballoon inflation lumen 3688 extends through the catheter shaft 3620from the proximal end 3604 to balloon inflation ports 3614 within theupstream sealing mechanism 3608 and the downstream sealing mechanism3607, respectively. Alternatively, separate inflation lumens may beprovided for independently inflating the upstream sealing mechanism 3608and the downstream sealing mechanism 3607. The guide wire lumen 3615extends from the proximal end 3604 of the catheter shaft 3620 to a guidewire port 3616 at the distal end 3606, of the catheter shaft 3620.

[0151] The proximal end 3604 of the catheter shaft 3620 is connected toa manifold 3650 with fittings for each of the catheter lumens. The archperfusion lumen 3610 is connected to a Y-fitting 3664 that has a barbconnector 3656 for connection to a perfusion pump or the like and a luerconnector 3658, which may be used for monitoring perfusion pressure, forwithdrawing fluid samples or for injecting medications or other fluids.The arch monitoring lumen 3611 is connected to a luer connector 3660 orother fitting suitable for connection to a pressure monitor. The ballooninflation lumen 3688 is connected to a luer connector 3666 or otherfitting suitable for connection to a syringe or balloon inflationdevice. The guide wire lumen 3615 is connected to a guide wire port 3676with a Touhy-Borst adapter or other hemostasis valve. The root pressurelumen 3618 is connected to a luer fitting 3672 or other suitablepressure fitting capable of being coupled to a pressure monitoringdevice.

[0152] Preferably, the perfusion shunt apparatus 3600 includes one ormore markers, which may include radiopaque markers and/or sonoreflectivemarkers, to enhance imaging of the perfusion shunt apparatus 3600 usingfluoroscopy or ultrasound, such as transesophageal echocardiography(TEE). An upstream radiopaque and/or sonoreflective marker ring 3640 onthe catheter shaft 3620 just proximal to the upstream sealing member3608 and a second, downstream radiopaque and/or sonoreflective markerring 3642 on the catheter shaft 2620 just distal to the downstreamsealing member 3607. Alternatively or additionally, radiopaque markersand/or sonoreflective markers may be placed on the sealing members 3607,3608 and/or the shunt conduit 3602 to show the position and/or thedeployment state of the perfusion shunt apparatus 3600.

[0153]FIG. 38 shows a schematic diagram of a sixth embodiment of thecirculatory support system of the present invention configured forselective, closed-loop perfusion of a patient's cerebral circulation andupper extremities, while the beating heart supplies the viscera andlower extremities with blood. In this embodiment of the circulatorysupport system, the aortic arch vessels are isolated using perfusionshunt apparatus 3800 and venous cannulation is provided by a superiorvena cava cannula 3899 similar to the one previously described inconnection with FIGS. 3 and 4, although any of the previously describedvenous cannula systems may be implemented.

[0154] Referring to FIG. 38, the arch perfusion shunt apparatus 3800 hasan expandable shunt device 3802 mounted on an elongated catheter shaft3820. The expandable shunt device 3802 has an expandable shunt conduit3812 an upstream sealing member 3808 at the upstream end of the device3802 and a downstream sealing member 3807 at the downstream end of thedevice 3802. The upstream and downstream sealing members 3808, 3807 maybe inflatable, toroidal balloons, as illustrated, or external flowcontrol valves may be used. A common inflation lumen 3888 oralternatively, separate inflation lumens (not shown) extend through thecatheter shaft 3820 from one or more inflation fittings 3866 on theproximal end 3804 of the catheter shaft 3820 to inflation ports 3814within the upstream occlusion member 3808 and the downstream occlusionmember 3807. The expandable shunt conduit 3802 is inserted into thepatient's aorta in a collapsed state and is expanded within the aorticarch when the inflated upstream sealing member 3808 is positionedbetween the aortic valve and the brachiocephalic artery and the inflateddownstream sealing member 3807 positioned downstream of the leftsubclavian artery creating a fluid channel shunt conduit 3812. An archperfusion lumen 3810, within the catheter shaft 3820, extends from aperfusion fitting 3864 at the proximal end 3804 of the catheter shaft3820 to one or more arch perfusion ports 3826 within the annular chamber3819 surrounding the shunt conduit 3802.

[0155] The cerebral loop of the circulatory support system is created byconnecting the venous drainage lumen 3897 of the superior vena cavacannula 3899 to the inflow 3851 of a first blood circulation pump 3857using suitable blood flow tubing 3877, then connecting the outflow 3853of the first blood circulation pump 3857 to the arch perfusion lumen3810 of the arch perfusion shunt apparatus 3800. The first bloodcirculation pump 3857 may be a peristaltic roller pump, a centrifugalblood pump or other suitable blood circulation pump. Preferably, thecerebral loop of the circulatory support system will also include avenous blood reservoir, a blood oxygenator and heat exchanger in serieswith the first blood circulation pump 3857. Optionally, vacuum assistmay be used to enhance venous drainage through the superior vena cavacannula 3899. Venous blood from the head and upper extremities entersthe patient's superior vena cava and is drained out through the venousdrainage lumen 3897 of the superior vena cava cannula 3899. The blood isoxygenated, cooled and recirculated by the first blood circulation pump3857 to the head and upper extremities through the arch perfusion lumen3810 of the arch perfusion shunt apparatus 3800.

[0156] In this embodiment of the invention, the corporeal loop of thecirculatory system is supplied by the patient's beating heart.Oxygenated blood from the heart passes through the expandable shuntconduit 3812 of the shunt device 3802, thus bypassing the aortic archvessels. From there, the blood flows through the descending aorta to theviscera and the lower extremities in the usual manner, returning to theheart via the inferior vena cava. The corporeal circulation is preventedfrom mixing with the cerebral circulation on the venous side by theocclusion balloon 3895 on the superior vena cava cannula 3899.

[0157] Perfusion shunt devices can also be used to isolate other organsystems within a patient's body, such as the renal system or hepaticsystem. A selective, closed-loop perfusion system can be created forthese organ systems by using an arterial perfusion shunt apparatus and avenous perfusion shunt apparatus connected to a blood circulation pump.

[0158]FIG. 39 shows a schematic diagram of a seventh embodiment of thecirculatory support system of the present invention configured forselective, closed-loop perfusion of a patient's renal system, while thebeating heart supplies the remainder of the circulatory system withblood. An arterial perfusion shunt apparatus 3900 is placed in thedescending aorta via the femoral artery so that the upstream sealingmember 3908 and the downstream sealing member 3907 isolate the ostia ofthe renal arteries from the aortic lumen. A venous perfusion shuntdevice 3999 is placed in the inferior vena cava via the femoral vein sothat the upstream sealing member 3995 and the downstream sealing member3985 isolate the ostia of the renal veins from the lumen of the inferiorvena cava.

[0159] A renal circulation loop is created within the circulatorysupport system by connecting the perfusion lumen 3987 of the venousperfusion shunt device 3999 to the inflow 3951 of a first bloodcirculation pump 3957 using suitable blood flow tubing 3977, thenconnecting the outflow 3953 of the first blood circulation pump 3957 tothe perfusion lumen 3910 of the arterial perfusion shunt device 3900.The first blood circulation pump 3957 may be a peristaltic roller pump,a centrifugal blood pump or other suitable blood circulation pump.Preferably, the renal circulation loop of the circulatory support systemwill also include a venous blood reservoir 3904, a blood oxygenator 3906and heat exchanger 3905 in series with the first blood circulation pump3957. Optionally, vacuum assist may be used to enhance venous drainagethrough the venous perfusion shunt device 3999. Venous blood from therenal arteries enters the annular chamber 3918 surrounding the shuntdevice 3922 and is drained out through the perfusion lumen 3987 in thecatheter shaft 3920. The blood is oxygenated, cooled and otherwiseconditioned and recirculated by the first blood circulation pump 3957 tothe renal arteries through the perfusion lumen 4010 of the arterialperfusion shunt device 3900. Alternatively, the renal circulation loopor other isolated circulatory loop may be perfused in the retrogradedirection.

[0160] The remainder of the circulatory system is supplied by thepatient's beating heart. Oxygenated blood from the heart flowing throughthe descending aorta passes through the shunt conduit 3912 of theexpandable shunt device 3932 of the arterial perfusion shunt apparatus3900, thus bypassing the renal arteries. From there, the blood flowsthrough the abdominal descending aorta to the rest of the viscera andthe lower extremities in the usual manner, returning to the heart viathe interior vena cava. Blood returning through the inferior vena cavapasses through the lumen 3962 of the expandable shunt device 3922 of thevenous perfusion shunt apparatus 3999, and bypasses the isolated renalcirculation.

[0161] While the present invention has been described herein withrespect to the exemplary embodiments and the best mode for practicingthe invention, it will be apparent to one of ordinary skill in the artthat many modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof. In addition, it canbe easily understood by one of ordinary skill in the art that anycombinataion of the venous cannulae and arterial cannulae as well as anyinsertion position can be used in combination to create the desiredsystem for a surgical intervention, the invention being defined by theclaims.

What is claimed is:
 1. A circulatory support system comprising: anarterial cannulation subsystem including a first arterial perfusionlumen and a second arterial perfusion lumen; a venous cannulationsubsystem including a first venous drainage lumen and a second venousdrainage lumen; a first circulation pump connected to the first arterialperfusion lumen of the arterial cannulation subsystem and to the firstvenous drainage lumen of the venous cannulation subsystem; and a secondcirculation pump connected to the second arterial perfusion lumen of thearterial cannulation subsystem and to the second venous drainage lumenof the venous cannulation subsystem.
 2. The circulatory support systemof claim 1, wherein: the arterial cannulation subsystem comprises anarterial cannula having an elongated tubular body with the firstarterial perfusion lumen and the second arterial perfusion lumenextending therethrough; and the venous cannulation subsystem comprises avenous cannula having an elongated tubular body with the first venousdrainage lumen and the second venous drainage lumen extendingtherethrough.
 3. The circulatory support system of claim 1, wherein: thearterial cannulation subsystem comprises an arterial cannula having anelongated tubular body with the first arterial perfusion lumen and thesecond arterial perfusion lumen extending therethrough; and the venouscannulation subsystem comprises a first venous cannula having anelongated tubular body with the first venous drainage lumen extendingtherethrough and a second venous cannula having an elongated tubularbody with the second venous drainage lumen extending therethrough. 4.The circulatory support system of claim 1, wherein: the arterialcannulation subsystem comprises a first arterial cannula having anelongated tubular body with the first arterial perfusion lumen extendingtherethrough and a second arterial cannula having an elongated tubularbody with the second arterial perfusion lumen extending therethrough;and the venous cannulation subsystem comprises a venous cannula havingan elongated tubular body with the first venous drainage lumen and thesecond venous drainage lumen extending therethrough.
 5. The circulatorysupport system of claim 1, wherein: the arterial cannulation subsystemcomprises a first arterial cannula having an elongated tubular body withthe first arterial perfusion lumen extending therethrough and a secondarterial cannula having an elongated tubular body with the secondarterial perfusion lumen extending therethrough; and the venouscannulation subsystem comprises a first venous cannula having anelongated tubular body with the first venous drainage lumen extendingtherethrough and a second venous cannula having an elongated tubularbody with the second venous drainage lumen extending therethrough. 6.The circulatory support system of claim 1, wherein the arterialcannulation subsystem comprises an arterial cannula having an elongatedtubular body with the first arterial perfusion lumen and the secondarterial perfusion lumen extending therethrough, wherein the firstarterial perfusion lumen connects to a first perfusion port and thesecond arterial perfusion lumen connects to a second perfusion port, andwherein the first perfusion port and the second perfusion port arespaced apart longitudinally along the elongated tubular body of thearterial cannula.
 7. The circulatory support system of claim 6, whereinthe arterial cannula further comprises a first arterial occlusion membermounted on an exterior of the elongated tubular body between the firstperfusion port and the second perfusion port.
 8. The circulatory supportsystem of claim 7, wherein the arterial cannula further comprises asecond arterial occlusion member mounted on an exterior of the elongatedtubular body distal to the first perfusion port and the second perfusionport.
 9. The circulatory support system of claim 8, wherein the arterialcannula further comprises a third arterial perfusion lumen extendingthrough the elongated tubular body to a third perfusion port distal tothe second arterial occlusion member.
 10. The circulatory support systemof claim 1, wherein the venous cannulation subsystem comprises a venouscannula having an elongated tubular body with the first venous drainagelumen and the second venous drainage lumen extending therethrough,wherein the first venous drainage lumen connects to a first drainageport and the second venous drainage lumen connects to a second drainageport, and wherein the first drainage port and the second drainage portare spaced apart longitudinally along the elongated tubular body of thevenous cannula.
 11. The circulatory support system of claim 10, whereinthe venous cannula further comprises a first venous occlusion membermounted on an exterior of the elongated tubular body between the firstdrainage port and the second drainage port.
 12. The circulatory supportsystem of claim 11, wherein the venous cannula further comprises asecond venous occlusion member mounted on an exterior of the elongatedtubular body distal to the first drainage port and the second drainageport.
 13. The circulatory support system of claim 12, wherein the venouscannula further comprises a third venous drainage lumen extendingthrough the elongated tubular body to a third drainage port distal tothe second venous occlusion member.
 14. The circulatory support systemof claim 1, wherein the venous cannulation subsystem comprises a firstvenous cannula having an elongated tubular body with the first venousdrainage lumen extending therethrough and a second venous cannula havingan elongated tubular body with the second venous drainage lumenextending therethrough, and wherein the first venous cannula furthercomprises a first venous occlusion member mounted on an exterior of theelongated tubular body.
 15. The circulatory support system of claim 14,wherein the second venous cannula further comprises a second venousocclusion member mounted on an exterior of the elongated tubular body.16. The circulatory support system of claim 1, wherein the arterialcannulation subsystem comprises a first arterial cannula having anelongated tubular body with the first arterial perfusion lumen extendingtherethrough and a second arterial cannula having an elongated tubularbody with the second arterial perfusion lumen extending therethrough,and wherein the first arterial cannula further comprises a firstarterial occlusion member mounted on an exterior of the elongatedtubular body.
 17. The circulatory support system of claim 16, whereinthe second arterial cannula further comprises a second arterialocclusion member mounted on an exterior of the elongated tubular body.18. The circulatory support system of claim 1, wherein the arterialcannulation subsystem comprises at least one arterial cannula having atleast one occlusion balloon mounted on an exterior thereof.
 19. Thecirculatory support system of claim 1, wherein the arterial cannulationsubsystem comprises at least one arterial cannula having at least oneexternal catheter valve mounted on an exterior thereof.
 20. Thecirculatory support system of claim 1, wherein the venous cannulationsubsystem comprises at least one venous cannula having at least oneocclusion balloon mounted on an exterior thereof.
 21. The circulatorysupport system of claim 1, wherein the venous cannulation subsystemcomprises at least one venous cannula having at least one externalcatheter valve mounted on an exterior thereof.
 22. The circulatorysupport system of claim 1, further comprising a first heat exchangerconnected in series with the first circulation pump.
 23. The circulatorysupport system of claim 22, further comprising a second heat exchangerconnected in series with the second circulation pump.
 24. Thecirculatory support system of claim 1, further comprising a first bloodoxygenator connected in series with the first circulation pump.
 25. Thecirculatory support system of claim 24, further comprising a secondblood oxygenator connected in series with the second circulation pump.26. The circulatory support system of claim 1, wherein the venouscannulation subsystem further comprises a first venous sensor forsensing a condition of a first portion of a patient's blood drained bythe first venous drainage lumen and a second venous sensor for sensing acondition of a second portion of the patient's blood drained by thesecond venous drainage lumen.
 27. The circulatory support system ofclaim 1, wherein the arterial cannulation subsystem further comprises afirst arterial sensor for sensing a condition of a first portion of apatient's blood perfused through the first arterial perfusion lumen anda second arterial sensor for sensing a condition of a second portion ofthe patient's blood perfused through the second arterial perfusionlumen.
 28. The circulatory support system of claim 1, wherein: thearterial cannulation subsystem is configured so that, when deployed in apatient's circulatory system, the first arterial perfusion lumencommunicates with the patient's aortic arch and arch vessels and thesecond arterial perfusion lumen communicates with the patient'sdescending aorta and branch vessels; and the venous cannulationsubsystem is configured so that, when deployed in the patient'scirculatory system, the first venous drainage lumen communicates withthe patient's superior vena cava and the second venous drainage lumencommunicates with the patient's inferior vena cava.
 29. The circulatorysupport system of claim 28, wherein: the arterial cannulation subsystemfurther comprises a third arterial perfusion lumen that communicateswith the patient's coronary arteries.
 30. The circulatory support systemof claim 28, wherein: the venous cannulation subsystem further comprisesa third venous lumen that communicates with the patient's coronarysinus.
 31. The circulatory support system of claim 28, furthercomprising: a coronary sinus catheter having a coronary sinus occlusionmember and an infusion lumen that communicates with the patient'scoronary sinus; and an infusion pump connected to the infusion lumen ofthe coronary sinus catheter.
 32. A method of circulatory support of apatient comprising: draining a first portion of the patient's blood froma first venous location in a first segment of the patient's circulatorysystem; draining a second portion of the patient's blood from a secondvenous location in a second segment of the patient's circulatory system;returning the first portion of the patient's blood to a first arteriallocation within the first segment of the patient's circulatory system;and returning the second portion of the patient's blood to a secondarterial location within the second segment of the patient's circulatorysystem.
 33. The method of claim 32, further comprising: conditioning thefirst portion of the patient's blood before returning the first portionto the first segment of the patient's circulatory system.
 34. The methodof claim 33, further comprising: conditioning the second portion of thepatient's blood before returning the second portion to the secondsegment of the patient's circulatory system.
 35. The method of claim 32,further comprising: cooling the first portion of the patient's bloodbefore returning the first portion to the first segment of the patient'scirculatory system.
 36. The method of claim 35, further comprising:cooling the second portion of the patient's blood before returning thesecond portion to the second segment of the patient's circulatorysystem.
 37. The method of claim 32, further comprising: oxygenating thefirst portion of the patient's blood before returning the first portionto the first segment of the patient's circulatory system.
 38. The methodof claim 37, further comprising: oxygenating the second portion of thepatient's blood before returning the second portion to the secondsegment of the patient's circulatory system.
 39. The method of claim 32,further comprising: adding protective or therapeutic agents to the firstportion of the patient's blood before returning the first portion to thefirst segment of the patient's circulatory system.
 40. The method ofclaim 39, further comprising: adding protective or therapeutic agents tothe second portion of the patient's blood before returning the secondportion to the second segment of the patient's circulatory system. 41.The method of claim 32, further comprising: isolating the first segmentof the patient's circulatory system from the second segment of thepatient's circulatory system on the arterial side of the patient'scirculatory system.
 42. The method of claim 41, further comprising:isolating the first segment of the patient's circulatory system from thesecond segment of the patient's circulatory system on the venous side ofthe patient's circulatory system.
 43. The method of claim 32, furthercomprising inflating an occlusion balloon on the arterial side of thepatient's circulatory system to isolate the first segment of thepatient's circulatory system from the second segment of the patient'scirculatory system.
 44. The method of claim 32, further comprisingexpanding an external catheter valve on the arterial side of thepatient's circulatory system to isolate the first segment of thepatient's circulatory system from the second segment of the patient'scirculatory system.
 45. The method of claim 32, further comprising:isolating the first segment of the patient's circulatory system from thesecond segment of the patient's circulatory system on the venous side ofthe patient's circulatory system.
 46. The method of claim 32, furthercomprising inflating an occlusion balloon on the venous side of thepatient's circulatory system to isolate the first segment of thepatient's circulatory system from the second segment of the patient'scirculatory system.
 47. The method of claim 32, further comprisingexpanding an external catheter valve on the venous side of the patient'scirculatory system to isolate the first segment of the patient'scirculatory system from the second segment of the patient's circulatorysystem.
 48. The method of claim 32, wherein: the first venous locationcomprises the patient's superior vena cava; the second venous locationcomprises the patient's inferior vena cava; the first arterial locationcomprises the patient's aortic arch and arch vessels; and the secondarterial location comprises the patient's descending aorta and branchvessels.
 49. The method of claim 48, further comprising returning athird portion of the patient's blood to the patient's coronary arteries.50. The method of claim 49, further comprising draining the thirdportion of the patient's blood from the patient's coronary sinus. 51.The method of claim 48, further comprising: conditioning the firstportion of the patient's blood to a temperature of approximately 32° C.or lower; and conditioning the second portion of the patient's blood toa temperature of approximately 32 to 37° C.
 52. The method of claim 48,further comprising: adding neuroprotective agents to the first portionof the patient's blood.
 53. The method of claim 48, further comprising:infusing a cardioplegic agent into the patient's coronary arteries. 54.The method of claim 48, further comprising: infusing a cardioplegicagent into the patient's coronary sinus.
 55. The method of claim 32,further comprising: sensing a condition of the first portion of thepatient's blood from the first venous location in the first segment ofthe patient's circulatory system; and sensing a condition of the secondportion of the patient's blood from the second venous location in thesecond segment of the patient's circulatory system.
 56. The method ofclaim 55, further comprising: sensing a condition of the first portionof the patient's blood returned to the first arterial location in thefirst segment of the patient's circulatory system; and sensing acondition of the second portion of the patient's blood returned to thesecond arterial location in the second segment of the patient'scirculatory system.
 57. A circulatory support system comprising: anarterial perfusion shunt device having a shunt conduit with an upstreamsealing member at an upstream end of the conduit and a downstreamsealing member at a downstream end of the conduit and a perfusion lumenin communication with an exterior of the shunt conduit between theupstream sealing member and the downstream sealing member; a venouscannula having an elongated tubular body with a venous drainage lumenextending therethrough; and a circulation pump connected to theperfusion lumen of the arterial perfusion shunt device and to the venousdrainage lumen of the venous cannula.
 58. A circulatory support systemcomprising: an arterial perfusion shunt device having a shunt conduitwith an upstream sealing member at an upstream end of the conduit and adownstream sealing member at a downstream end of the conduit and aperfusion lumen in communication with an exterior of the shunt conduitbetween the upstream sealing member and the downstream sealing member;and a venous perfusion shunt device having a shunt conduit with anupstream sealing member at an upstream end of the conduit and adownstream sealing member at a downstream end of the conduit and adrainage lumen in communication with an exterior of the shunt conduitbetween the upstream sealing member and the downstream sealing member.59. The circulatory support system of claim 58, further comprising acirculation pump connected to the perfusion lumen of the arterialperfusion shunt device and to the drainage lumen of the venous perfusionshunt device.
 60. A venous drainage cannula comprising: an elongatedtubular body with a first venous drainage lumen and a second venousdrainage lumen extending therethrough; and wherein the first venousdrainage lumen connects to a first drainage port and the second venousdrainage lumen connects to a second drainage port and wherein the firstdrainage port and the second drainage port are spaced apartlongitudinally along the elongated tubular body of the venous cannula.61. The venous drainage cannula of claim 60, further comprising a firstvenous occlusion member mounted on an exterior of the elongated tubularbody between the first drainage port and the second drainage port. 62.The venous drainage cannula of claim 61, further comprising a secondvenous occlusion member mounted on an exterior of the elongated tubularbody distal to the first drainage port and the second drainage port. 63.The venous drainage cannula of claim 62, further comprising a thirdvenous drainage lumen extending through the elongated tubular body to athird drainage port distal to the second venous occlusion member. 64.The venous drainage cannula of claim 60, further comprising at least oneocclusion balloon mounted on an exterior of the elongated tubular body.65. The venous drainage cannula of claim 60, further comprising at leastone external catheter valve mounted on an exterior of the elongatedtubular body.
 66. The venous drainage cannula of claim 60, furthercomprising a first venous sensor for sensing a condition of a firstposition of a patient's blood drained by the first venous drainage lumenand a second venous sensor for sensing a condition of a second portionof the patient's blood drained by the second venous drainage lumen.